Blue Sky Bio C0297 Dental Implant Systems Owner’s Manual

Blue Sky Bio C0297 Dental Implant Systems

Product Information

• Specifications
  • Manufacturer: Blue Sky Bio, LLC
  • Product Type: Dental Implant Systems
  • Material: Medical-grade titanium alloy, chrome-cobalt alloy, or gold alloy
  • Sterilization: Gamma radiation
  • Regulatory Compliance: FDA regulations, CE marking for European Community

Product Usage Instructions

• MRI Safety Information

  • Blue Sky Bio implants and abutments have not been evaluated for safety and compatibility in the Magnetic Resonance (MR) Environment.

  • It is advised to avoid scanning patients with Blue Sky Bio implants as it may result in patient injury.

• Procedural Precautions

  • Proper stress distribution through passive adaptation and fitting of the bridge to the implant abutments is crucial.

  • Immediate loading and immediate temporization need additional precautions and are unsuitable for all cases.

  • Care must be taken to prevent swallowing or aspiration of small prosthetic components.

• Warnings

  • Avoid fabricating zirconia superstructures, casting one-piece abutments, or milling abutments that exceed design parameters.

• Follow Up Care

  • Instruct patients on oral hygiene and care of implants and restorations. Schedule periodic follow-up appointments to ensure the proper function of implants and surrounding tissue health.

• Cleaning Instructions for Reusable Instruments

  • Rinse with cool-to-lukewarm water for 2.5 minutes.
  • Place parts in an ultrasonic cleaner with enzymatic detergent diluted with tap water as per the manufacturer’s guidelines. Sonicate for 10 minutes.
  • Rinse with tap water for three minutes.

• Method of Supply

  • Blue Sky Bio, LLC implants are made from medical-grade titanium alloy, while abutments are made from medical-grade titanium alloy,chrome-cobalt alloy, or gold alloy.

• Bail

  • The sale of this device is restricted to, or by the order of, licensed physicians or dentists.

FAQs

• Q: Can Blue Sky Bio implants be used in MRI environments?
  • A: Blue Sky Bio implants have not been evaluated for MRI safety; therefore, avoiding scanning patients with these implants is recommended to prevent potential injuries.
• Q: What materials are Blue Sky Bio abutments made of?
  • A: Blue Sky Bio abutments are made from medical-grade titanium, chrome-cobalt, or gold alloys.

SYMBOLS

Instructions For Use

(For US Only) Blue Sky Bio, LLC Dental Implant Systems

Indications

• The implant systems are intended for use in supporting single or multiple restorations in the fully or partially edentulous mandibular or maxillary alveolar process.

Contraindications

• Implants should not be placed anytime when there are general contraindications associated with elective oral surgery.
• Absolute and relative contraindications include but are not limited to Titanium allergy (Chrome, Cobalt or Molybdenum allergy for abutments manufactured from such alloys), cardiac and vascular disease, bleeding disorders, psychological disorders, uncontrolled diabetes mellitus, mineral, bone, or connective tissue disorders, renal disease, hepatic disease, auto-immune disorders, decreased immune function due to disease or medications, infectious disorders, and adverse conditions caused by medications.
• Further, relative contraindications include poor oral hygiene, bruxism, malnutrition, alcoholism, tobacco usage, and a history of radiation therapy.
• In addition, the patient needs an adequate volume of residual bone for the placement of implants of sufficient size and number to support the anticipated functional loads to which the patient will subject these implants.
• Narrow implants and angled abutments are not intended for use in the posterior region of the mouth.

Warning

• Implants should be placed and restored only by practitioners who are licensed and trained to perform these procedures.
• Adequate preoperative studies should be performed to examine the anatomic structures and to assess the biomechanical, functional, and esthetic requirements of each case.
• Radiographs or other diagnostic reviews should be performed to determine the position and topography of the maxillary sinus, nasal cavities, inferior alveolar nerve, mental foramen, natural tooth positions and other anatomical features that may affect implant placement or prognosis.
• Consultation between the surgeon, restorative dentist, and dental laboratory is essential for success.
• Risks of implant placement and restoration include but are not limited to infection, implant failure, loss of bone and soft tissue, unfavourable aesthetic result, anesthesia, dysesthesia and paresthesia in the oral and facial areas, sinus infection, dislodgement of implants and instruments in the surrounding structures, damage to adjacent teeth, non-restorable implants, fracture of implants or restorative components, and loosening of implants or restorative components.
• Each implant system has unique measuring characteristics to allow full seating of the implant to the desired depth.
• In some instances, drill length reference lines measure longer than the stated length of the implant.
• It is recommended that the implant surgeon be thoroughly familiar with the specific measurement system being utilized and provide a suitable safety margin adjacent to any teeth and vital structures.
• Failure to recognize the difference between the actual length of the drill and radiographic measurements can result in permanent injury to the nerves or other vital structures by drilling beyond the depth intended, potentially resulting in permanent numbness to the lower lip and chin or other injuries.
• Each implant system has specific design characteristics for mating implants, abutments, prosthetic components, and instrumentation.
• Combining instruments and components that are not configured or dimensioned for correct mating can lead to mechanical failure of components, damage to tissue, or unsatisfactory aesthetic results therefore one hundred per cent success cannot be guaranteed.
• Lack of adequate quantity and/or quality of remaining bone, infection, inadequate surgical technique, poor patient oral hygiene, and generalized disease are some potential causes for failure of osseointegration, both immediately after surgery or after osseointegration is initially achieved.
• Pre-operative hard tissue or soft tissue deficits may yield a compromised aesthetic result or unfavourable implant angulation. Concerning children, treatment is not recommended until the completion of alveolar growth has been verified.

MRI Safety Information

• Blue Sky Bio implants and abutments have not been evaluated for safety and compatibility in the Magnetic Resonance (MR) Environment.
• Blue Sky Bio implants and abutments have not been tested for heating, migration, or image artifacts in the MR environment.
• The safety of Blue Sky Bio implants and abutments in the MR environment is unknown.
• Scanning a patient with Blue Sky Bio implants and abutments may result in patient injury.

Procedural Precautions, Surgery

• All efforts must be made to minimize damage to the host tissue.
• In particular, special attention must be paid to thermal and surgical trauma and to the elimination of contaminants and sources of infection.
• The surgical procedure requires a high degree of precision and care.
• Any divergence from the principle of least possible trauma at implant installation increases the risk of failure to establish osseointegration.
• All drilling procedures should be performed at a maximum 1000-2000 RPM with copious irrigation.
• The use of sharp drills, sufficient irrigation, an in-and-out drilling motion, short cutting cycles, waiting for the bone to cool, and the use of pilot drills in successively increasing sizes is essential.
• Please refer to our website for the specific sequence of drills for each implant type and size.
• Special care should be taken to avoid over or under-preparation of the osteotomy. Implants should be inserted in such a way that they are stable and lack any mobility.
• Excessive insertion torque (greater than 60 Ncm) may lead to damage to the implant or instruments and fracture or necrosis of the bone site.
• All instruments used in surgery must be maintained in good condition and care must be taken that the instruments do not damage the implants or other components. Precautions must be taken to avoid the swallowing or aspiration of components used in implant dentistry.
• After the implant installation, the surgeon’s evaluation of bone quality and initial stability will determine when implants may be loaded. An appropriate follow-up protocol should be followed.

Procedural Precautions, Prosthetics

• Especially important is proper stress distribution through passive adaptation and fitting of the bridge to the implant abutments, adjusting occlusion to the opposing jaw, and avoiding excessive transverse loading forces.
• Immediate loading and immediate temporization require additional precautions and are unsuitable for all cases.
• Because of the small size of prosthetic components, care must be taken so that they are not swallowed or aspirated by the patient.

Instructions For Abutments For Restoration Of Blue Sky Bio, LLC Implants

• After adequate osseointegration, the implants should be uncovered, if necessary, and the cover screw should be removed. The internal part of the implant should be irrigated, freed from debris, and dried. If necessary, a healing abutment should be placed and the tissue should be allowed to heal around the healing abutment. A final abutment that is compatible with the implant should be chosen. If the abutment is modified at the chair side, it is advisable to make an impression and make a preliminary model to identify any undercuts before making the final impression. A carbide or diamond bur can be used with copious irrigation to remove the undercuts. The indexing feature of the abutment (e.g. octagon or trilobe) should match the internal indexing feature of the implant. Adequate seating can be verified with a radiograph.
• If the abutment is modified in a laboratory, proper orientation of the abutment into the implant should be identified using a transfer jig or any other transfer device. Final abutment seating should be performed using an insertion driver compatible with the selected implant system and a torque wrench applying 30 Ncm of torque on the abutment or fastening screw.
• Abutments should not be over-prepared, and the retention of restoration and the strength of the abutment should be taken into consideration. It is recommended that less than 50% ofthe structure of customizable abutments and less than 30% of straight abutments be removed. Do not modify abutment at the junction with the implant. The abutment angle should not be changed from the specified angulation. Substantial modification of the abutment may compromise the structural integrity and can lead to premature failure. Do not modify abutment at the junction with the implant.
• A restoration should be fabricated and inserted while making sure that the restoration is stable and occlusal load is appropriate. Multi-unit abutments for fixed restorations are to be used only for multiple splinted restorations.

Instructions for Base Abutments and for Custom abutments from Titanium Preformed Blanks

• Indications for use
  • Blue Sky Bio CAD-CAM Abutments are intended to be used in conjunction with Blue Sky Bio endosseous dental implants in the maxillary or mandibular arch to provide support for single or multi-unit prosthetic restorations.
  • All digitally designed abutments for use with Blue Sky Bio CAD-CAM Abutments are intended to be sent to a Blue Sky Bio validated milling centre for manufacture.
• Description
  • Blue Sky Bio CAD-CAM Abutments include Titanium Base Abutments, Cobalt Base Abutments, and Titanium Blank Abutments.
  • Titanium Base Abutments and Cobalt Base Abutments are provided in straight and 15° angled designs.
  • Titanium Base Abutments and Cobalt Base abutments can support a zirconia superstructure or a final restoration. Cobalt Base Abutments may be cast to a final one-piece abutment.
• Fabrication of Suprastructure for Titanium and Cobalt Base Abutments
  • The Blue Sky Bio validated milling center is sent the intraoral scan STL file and designs the superstructure using a computer software (CAD) the according to the design parameters below and the interproximal space available.
  • The recommended material for milling (CAM) the superstructure is Zirconia Y-TZP, conforming to ISO 13356 Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).
• Superstructure Bonding
  • The superstructure may be bonded to the abutment by the milling center, or may be bonded by the clinician. The following instructions are to be followed in either case.
  • Inspect the abutment for any defects. If any visible defects are present, do not use the abutment.
  • Grit blasting of the base abutment is not required for proper bonding due to the retentive features on the base.
  • Cleaning the base and the superstructure. Confirm there is no debris, grease, or other foreign matter present on any area to be cemented.
  • Multilink Hybrid Abutment Cement (Ivoclar Vivadent AG) is recommended. Refer to the manufacturer’s instructions for proper mixing.
  • Apply cement to the contact surfaces of the base abutment and press the superstructure onto the abutment following the anti-rotational features.
  • Verify that both components are seated completely.
  • Remove excess cement immediately and refer to the manufacturer’s instructions for proper curing procedures.
  • Sterilize the abutment according to the steam autoclaving instructions.
• Cobalt Base Abutments Workflow for Casting
  • Cobalt Base Abutments (Straight) can be used as a base for cast-to-straight abutments only.
  • Angled Cobalt Base Abutments are not indicated for cast-to-final abutments).
  • The final one-piece abutment is fabricated using the standard lost wax casting technique.
• Blue Sky Bio Titanium Preformed Blank Abutments
  • The Blue Sky Bio validated milling centre is sent the intraoral scan STL file and designs the final abutment using computer software (CAD) the according to the design parameters below and the interproximal space available.
  • The abutment is machined (CAM) using standard milling techniques.

Design Parameters

The design parameters for Titanium Base Abutments, Cobalt Base Abutments (including caste-to abutments) and for custom abutments fabricated from Titanium Preformed Blank

Abutments are:

• Minimum wall thickness – 0.4 mm
• Minimum post height for single-unit restorations – 4.0 mm;
• Minimum gingival height – 0.5 mm
• Maximum gingival height – 6.7 mm

Maximum angulation

• Base Abutments (Straight) – superstructure maximum angle – 30°
• Base Abutments (Angled 15°) – superstructure maximum angle – 15° (total of 30°)
• Final custom milled abutments – 30°
• Cobalt cast-to abutments – 0°
• Maximum divergence or angular correction between two implants is 60°

Warning

• It is contraindicated to fabricate a zirconia superstructure and to cast a one-piece abutment, or to mill an abutment that exceeds the design parameters.

Follow Up Care

• Patients should be instructed in appropriate oral hygiene and care of the implants and restorations. Periodic follow-up appointments should be made to confirm and maintain adequate function of the implants and the health of the surrounding tissues.

Sterility

• All implants are supplied sterile and are for single use only before the labelled expiration date (if applicable).
• Do not use implants if the packaging has been damaged or previously opened. Abutments and instruments are supplied non-sterile and must be cleaned and sterilized before use.
• Steam Sterilization procedure: Place the autoclave pouch containing the item to be sterilized into the autoclave and follow the specific instructions provided by the manufacturer for pouched items.
• In general, a pouch must be sterilized by heating for 30 minutes at 250 degrees F (121 degrees C).

Cleaning instructions for reusable instruments

• Rinse with cool-to-lukewarm water for two and one-half minutes. For all parts place in an ultrasonic cleaner with an enzymatic detergent diluted with tap water per the manufacturer’s guidelines. Sonicate for 10 minutes. Rinse with tap water for three minutes.

Method of Supply

• Blue Sky Bio, LLC implants are made out of medical-grade titanium alloy.
• Blue Sky Bio, LLC abutments are made out of medical-grade titanium alloy, chrome-cobalt alloy or gold alloy.

Caution

• The sale of this device is restricted to, or by the order of, licensed physicians or dentists.

Implant Card Instructions for Completion

An implant card has been provided with the implant device. It is intended to be completed by the healthcare provider; and then given to the patient.

1. Name of the patient or patient ID – To be completed by healthcare institution/provider
2. Date of implantation – To be completed by healthcare institution/provider
3. Name and address of the healthcare institution and provider – To be completed by the healthcare institution/provider
4. Barcode to patient implant information – Present on Implant Card

www.blueskybio.com/pages/patientimplantinfo.

Locations of text to be filled on the Left. Example of a completed implant card on the right with written information in blue. Symbolling located on the device-specific side of the implant card can be found on the first page of the IFU.

Instructions For Use (For UK, Europe, Australia, and Canada) Blue Sky Bio, LLC Dental Implant Systems
Indications

• The implant systems are intended for use in supporting single or multiple restorations in the fully or partially edentulous mandibular or maxillary alveolar process.

Contraindications

• Implants should not be placed at anytime when there are general contraindications associated with elective oral surgery. Absolute and relative contraindications include, but are not limited to: Titanium allergy, cardiac and vascular disease, bleeding disorders, psychological disorders, uncontrolled diabetes mellitus, mineral, bone, or connective tissue disorders, renal disease, hepatic disease, auto-immune disorders, decreased immune function due to disease or medications, infectious disorders, and adverse conditions caused by medications.
• Further, relative contraindications include poor oral hygiene, bruxism, malnutrition, alcoholism, tobacco usage, and a history of radiation therapy. In addition, the patient needs an adequate volume of residual bone for the placement of implants of sufficient size and number to support the anticipated functional loads to which the patient will subject these implants.
• Narrow implants and angled abutments are not intended for use in the posterior region of the mouth.

Warning

• Implants should be placed and restored only by practitioners who are licensed and trained to perform these procedures. Adequate preoperative studies should be performed to examine the anatomic structures and to assess the biomechanical, functional, and esthetic requirements of each case.
• Radiographs or other diagnostic reviews should be performed to determine the position and topography of the maxillary sinus, nasal cavities, inferior alveolar nerve, mental foramen, natural tooth positions and other anatomical features that may affect implant placement or prognosis.
• Consultation between the surgeon, restorative dentist, and dental laboratory is essential for success.
• Risks of implant placement and restoration include but are not limited to: infection, implant failure, loss of bone and soft tissue, unfavourable aesthetic result, anesthesia, dysesthesia and paresthesia in the oral and facial areas, sinus infection, dislodgement of implants and instruments in the surrounding structures, damage to adjacent teeth, non-restorable implants, fracture of implants or restorative components, and loosening of implants or restorative components.
• Each implant system has unique measuring characteristics to allow full seating of the implant to the desired depth.
• In some instances, drill length reference lines measure longer than the stated length of the implant.
• It is recommended that the implant surgeon be thoroughly familiar with the specific measurement system being utilized and provide a suitable safety margin adjacent to any teeth and vital structures.
• Failure to recognize the difference between the actual length of the drill and radiographic measurements can result in permanent injury to the nerves or other vital structures by drilling beyond the depth intended, potentially resulting in permanent numbness to the lower lip and chin or other injuries.
• Each implant system has specific design characteristics for mating implants, abutments, prosthetic components, and instrumentation.
• Combining instruments and components that are not configured or dimensioned for correct mating can lead to mechanical failure of components, damage to tissue, or unsatisfactory aesthetic results therefore one hundred per cent success cannot be guaranteed.
• Lack of adequate quantity and/or quality of remaining bone, infection, inadequate surgical technique, poor patient oral hygiene, and generalized disease are some potential causes for failure of osseointegration, both immediately after surgery or after osseointegration is initially achieved. Pre-operative hard tissue or soft tissue deficits may yield a compromised aesthetic result or unfavourable implant angulation.
• Concerning children, treatment is not recommended until the completion of alveolar growth has been verified.

Procedural Precautions, Surgery

• All efforts must be made to minimize damage to the host tissue. In particular, special attention must be paid to thermal and surgical trauma and to the elimination of contaminants and sources of infection.
• The surgical procedure requires a high degree of precision and care. Any divergence from the principle of least possible trauma at implant installation increases the risk of failure to establish osseointegration.
• All drilling procedures should be performed at a maximum 1000-2000 RPM with copious irrigation. The use of sharp drills, sufficient irrigation, an in-and-out drilling motion, short cutting cycles, waiting for the bone to cool, and use of pilot drills in successively increasing sizes are essential.
• Please refer to our website for the specific sequence of drills for each implant type and size. Special care should be taken to avoid over or under-preparation of the osteotomy.
• Implants should be inserted in such a way that they are stable and lack any mobility. Excessive insertion torque (greater than 60 Ncm) may lead to damage to the implant or instruments and fracture or necrosis of the bone site.
• All instruments used in surgery must be maintained in good condition and care must be taken that the instruments do not damage the implants or other components. Precautions must be taken to avoid the swallowing or aspiration of components used in implant dentistry.
• After the implant installation, the surgeon’s evaluation of bone quality and initial stability will determine when implants may be loaded.
• An appropriate follow-up protocol should be followed.

Procedural Precautions, Prosthetics

• Especially important is proper stress distribution through passive adaptation and fitting of the bridge to the implant abutments, adjusting occlusion to the opposing jaw, and avoiding excessive transverse loading forces.
• Immediate loading and immediate temporization require additional precautions and are unsuitable for all cases. Because of the small size of prosthetic components, care must be taken so that they are not swallowed or aspirated by the patient.

Instructions For Abutments For Restoration Of Blue Sky Bio, LLC Implants

• After adequate osseointegration, the implants should be uncovered, if necessary, and the cover screw should be removed. The internal part of the implant should be irrigated, freed from debris, and dried.
• If necessary, a healing abutment should be placed and the tissue should be allowed to heal around the healing abutment.
• A final abutment that is compatible with the implant should be chosen. If the abutment is modified at the chairside, it is advisable to make an impression and make a preliminary model to identify any undercuts before making the final impression.
• A carbide or diamond bur can be used with copious irrigation to remove the undercuts. The indexing feature of the abutment (e.g. octagon or trilobe) should match the internal indexing feature of the implant. Adequate seating can be verified with a radiograph.
• If the abutment is modified in a laboratory, proper orientation of the abutment into the implant should be identified using a transfer jig or any other transfer device. Final abutment seating should be performed using an insertion driver compatible with the selected implant system and a torque wrench applying 30 Ncm of torque on the abutment or fastening screw.
• Abutments should not be over-prepared, and the retention of restoration and the strength of the abutment should be taken into consideration.
• It is recommended that less than 50% of the structure of customizable abutments and less than 30% of straight abutments be removed.
• Do not modify abutment at the junction with the implant. The abutment angle should not be changed from the specified angulation. Substantial modification of the abutment may compromise the structural integrity and can lead to premature failure.
• Do not modify abutment at the junction with the implant. A restoration should be fabricated and inserted while making sure that the restoration is stable and occlusal load is appropriate.
• Multi-unit abutments for fixed restorations are to be used only for multiple splinted restorations.

Follow Up Care

• Patients should be instructed in appropriate oral hygiene and care of the implants and restorations. Periodic follow-up appointments should be made to confirm and maintain adequate function of the implants and the health of the surrounding tissues.

Sterility

• All implants are supplied sterile and are for single use only before the labelled expiration date (if applicable). Do not use implants if the packaging has been damaged or previously opened.
• Abutments and instruments are supplied non-sterile and must be cleaned and sterilized before use.
• Steam Sterilization procedure: Place the autoclave pouch containing item to be sterilized into the autoclave and follow the specific instructions provided by the manufacturer for pouched items. In general, a pouch must be sterilized by heating for 30 minutes at 250 deg F (121 deg C).

Cleaning instructions for reusable instruments

• Rinse with cool-to-lukewarm water for two and one-half minutes. For all parts place in an ultrasonic cleaner with an enzymatic detergent diluted with tap water per the manufacturer’s guidelines. Sonicate for 10 minutes. Rinse with tap water for three minutes.

Method of Supply

• Blue Sky Bio, LLC implants and abutments are made out of medical-grade titanium or gold alloy.

Caution

• The sale of this device is restricted to, or by the order of, licensed physicians or dentists.

Implant Card Instructions for Completion
An implant card has been provided with the implant device. It is intended to be completed by the healthcare provider; then given to the patient.

1. Name of the patient or patient ID – To be completed by healthcare institution/provider
2. Date of implantation – To be completed by healthcare institution/provider
3. Name and address of the healthcare institution and provider – To be completed by the healthcare institution/provider
4. Barcode to patient implant information – Present on Implant Card

www.blueskybio.com/pages/patientimplantinfo.
Locations of text to be filled on the Left. Example of a completed implant card on the right with written information in blue. Symbolling located on the device-specific side of the implant card can be found on the first page of the IFU.

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