Anthogyr BL X3 Axiom Bone Level X3 Implants Instructions

Anthogyr BL X3 Axiom Bone Level X3 Implants

Product Information: Surgical User Guide A BL X3

Specifications

• Implant Code : XT for BL X3
• Pitch : 2 mm
• Drilling Depth: Varies based on implant length
• Theoretical Crestal Edge: 0.5 mm
• Sub-crestal Position : 0.0 mm
• Drill Diameter : 2.7 mm
• Connection Type : Extended, indexed, tri-lobe Morse-taper connection
• Threading: M1.6

Product Usage Instructions

Presentation of the Range
The Surgical User Guide provides information on the Anthogyr Bone Level X3 range of implants. The range includes implants with different lengths and body configurations.

• Terminology
  The user guide explains the terminology used in relation to the Anthogyr Bone Level X3 implants, including terms like “Body” and “Apex”.

• Colour Codes
  The Anthogyr implant cardboard box is color-coded to differentiate between Tissue Level implants and Bone Level implants.

• Codification
  The implants are coded with XT for BL X3, followed by specific numbers that indicate the length of the implant body.

Technical Features
The technical features of the Bone Level X3 implants include pitch, drilling depth, crestal edge position, drill diameter, connection type, and threading.

1. Common Surgical Kits
   The user guide provides information on the common surgical kits that are used with the Anthogyr Bone Level X3 implants. These kits include various instruments and tools for implant placement.

2. Implant Planning
   The user guide explains the process of implant planning, including the considerations and steps involved in determining the optimal placement of the Bone Level X3 implants.

3. Preparation of Prosthetic Site
   The user guide provides instructions on the preparation of the prosthetic site before implant placement. This includes information on implantology peripherals and specific tools like drills stops kit, MG implant pre- positioning system, dual function depth gauge, angled drill guide, etc.

4. Healing
   The user guide provides information on the healing process after implant placement, including post-operative care and guidelines for optimal healing.

5. Surgical Instruments
   The user guide lists and describes the surgical instruments used in conjunction with the Anthogyr Bone Level X3 implants, including reversible ratchet wrench, manual surgical wrench, implant screwing wrenches and mandrels, S drills, L drills, depth and parallelism gauge, mandrel extension, pointer drill, etc.

6. Cleaning and Sterilization
   The user guide provides guidelines for cleaning and sterilizing the surgical instruments and implants to ensure proper infection control.

7. Component Reference Numbers
   The user guide includes reference numbers for the components of the Anthogyr Bone Level X3 implants and surgical kits.

Frequently Asked Questions (FAQ)

• Q: Can I find the instructions for use online?
  A: Yes, you can find the instructions for use (instructions and manuals) for Anthogyr implants and prosthetics parts in PDF format on the site ifu.anthogyr.com using a PDF reader (Adobe Player).

• Q: How does the site work?
  A: The site ifu.anthogyr.com provides information updates and access to instructions for use (instructions and manuals) for Anthogyr implants and prosthetics parts in PDF format.

• Q: Can I sterilize the surgical kit?
  A: Yes, the surgical kit is designed with medical-grade materials so that it can tolerate thermal disinfection and sterilization via autoclave.

Thank yor for your trust and for choosing the Axiom® Multi Level® implant solution.

• This document contains necessary information for using the Axiom® Multi Level® device with restoration protocols specific to the Axiom® Bone Level and Axiom® Tissue Level systems, as well as the entire component list.
• Success for you means success for us. Our marketing network and team of experts is always available to you for any further information that you may need.
• This user guide alone is not sufficient for the safe use of Anthogyr medical devices. Please refer to the product specific instructions for use available at ifu.anthogyr.com
• This manual cancels and replaces all previous versions.

INSTRUCTIONS AVAILABLE ONLINE ifu.anthogyr.com

You can now find instructions for use (instructions and manuals) for Anthogyr implants and prosthetics parts in PDF format on our site ifu.anthogyr.com using a PDF reader (Adobe Player).

HOW DOES THE SITE WORK ?

This portal provides the latest instructions for using Anthogyr products. To find the instructions for your device, please follow these steps

1. Enter your product reference number, description or GTIN code (Global Trade Item Number) in the search field.

2. Press submit
   Your product’s instructions will be available in PDF format, which you can consult online and/or print.

3. Select a language
   Our instructions are available in several languages. To select the language you need, click the language choice menu.
   This site is optimized for a 1024 x 768 px resolution screen to display instructions on PC or Mac with the following browser versions: Microsoft Internet Explorer 11 or higher, Safari 7.0 or higher (Mac only), Chrome 43 or higher, Firefox 38.0 and higher, and IOS and Android.

INFORMATION UPDATES

• Instructions for use are updated regularly and indicated by the “New” pictogram. Updated instructions can impact patient safety
• For this reason, we suggest you to avoid local back-ups and advise you to always check the Anthogyr portal.
• To access archived instructions, click on “View old document versions.”
• You can also receive paper copies of instructions at no additional cost.
• To receive paper copies, fill out the form available under the “Contact” tab or include a request with your next order. Make sure to include your desired language.
• The document will be delivered to you within 7 calendar days.
• We are available if you have any comments or suggestions, via the “Contact” tab.

Axiom® Multi-Level®

Presentation of the range

• TERMINOLOGY
  • Axiom® BL: Axiom® Bone Level
• COLOUR CODES
  • A colour code is present on the Anthogyr implant cardboard box to quickly differentiate Tissue Level implants of Bone Level implants.
• CODIFICATION
  • Not all configurations are available, please refer to the catalogue at the end of this document.

TECHNICAL FEATURES

Axiom® BL X3 implants are made of Ti6Al-4V-ELI, high-resistance biocompatible material (in compliance with US standard ASTM F136 and international ISO 5832-3 standard). They benefit from a BCP osseo-conductive surface treatment (surface treatment with BCP sand-blasting.

Axiom® BL X3 Profile

• Conical
• Reverse conical neck (Except XT34)
• Pitch of the Axiom® BL X3:

APICO-CORONARY POSITIONING OF AXIOM® MULTI LEVEL® IMPLANTS
Surgical protocols for Axiom® BL and TL include a 0.5 mm sub-crestal placement of the body of the implants. However, the practitioner can adjust the sub- crestal implant position according to the clinical situation and anatomic obstacles. In this case, they must adapt the drilling protocol.

Axiom® BL Connections
With its single diameter 2.7 mm prosthetic connection, the Axiom® BL prosthetic range is compatible with all Axiom® BL REG, Axiom® BL PX and Axiom® X3 implants, regardless of the chosen implant diameter.

Common surgical kits
AXIOM® MULTI LEVEL® SURGICAL KIT COMPACT AND COMMON FOR AXIOM® BL AND AXIOM® TL IMPLANTS A reversible ratchet wrench is available in the surgical kit Axiom® Multi Level® (Ref. INMODOPS3 & INMODOPS3L). However, a dynamometric surgical ratchet wrench is available as an option (Ref. INCCDC).

Please note

Axiom® BL an TL screwing tools are differentiated by a color treatment

• To place Axiom® BL implants, use grey instruments.
• To place Axiom® TL implants, use gold instruments.
• The use of a non adapted screwing tool can damage the implant connection.

The Axiom® Multi Level® kit (Ref. INMODOPS3) is used for the placement of Axiom® BL X3 implants, with diameters Ø3.4 / Ø4.0 / Ø4.6 / Ø5.2.

The Axiom® Multi Level® kit, version L (Ref. INMODOPS3L) is used for the placement of Axiom® BL X3 implants, with diameters Ø3.4 / Ø4.0 / Ø4.6 / Ø5.2 / Ø5.8 / Ø6.4.

TECHNICAL SPECIFICATIONS

• The surgical kit is designed with medical-grade materials so that it can tolerate thermal disinfection and sterilization via autoclave.
• Adjustable protective caps make the surgical kit modular to optimize instrument access during surgery.

Axiom® BL, Bone Level

Implant planning
The surgical protocol for Axiom® BL X3 accounts for a 0.5 mm sub-crestal placement of the body of the implants. However, the practitioner can adjust the sub-crestal implant position according to the clinical situation and anatomic obstacles. They must also then adapt the drilling protocol.
Use your implant planning software with the Axiom® BL X3 library or Axiom® BL X3-Ray template.

Axiom® BL X3 surgical protocol

Positioning the Axiom® BL X3 implant
Before opening the package, always check the implant size and the design (REG, PX or X3). See identification label on the top flap of the cardboard box.

All implants come with removable, repositionable traceability labels which must be included in the patient record. They must be saved in the patient’s medical file.

OPENING THE PACKAGE
The implant packaging is made up of several levels

• A cardboard box protecting it during transport
• A sealed blister enabling to preserve the sterility
• A primary packaging preserving the implant.

• Place the outer box on the back table to remove the blister pack.
• Open the sealed pack without touching the inside of the blister. Gently drop the primary packaging onto the sterile fie.

DELIVERING THE IMPLANT INTO THE MOUTH
Please note

• All handlings should be done so as to avoid direct contact with the exterior surface of the implant. Systematically secure the implant handling against the risk of falling into the mouth.
• The implant is movable once the tube and stopper have been opened. Make sure to keep the tube upright when handling, with the implant access pointing upward.

CHECKING OF THE RETENTION OF THE IMPLANT
The limit of the laser marking indicates that the mandrel is correctly positioned in the implant and thus guarantees the correct retention of the implant.

INSERTION OF THE IMPLANT

POSITIONING WITH THE CONTRA-ANGLE

• Adjust the speed of the contra-angle. Tighten the implant to the desired depth.
• Recommended speeds for implant tightening : 15 rpm

Note
Regulary check the tightening torque in order not to exceed 80 N.cm. Do not hesitate to unscrew and re-screw during the implant’s insertion to reduces crewing forces.

MANUAL POSITIONING: With the surgical ratchet

• Manually pre-tighten the implant into the implant shaft using the torque wrench or the manual screw-down application instrument(1) (Ref. INPIM/INPIL).
• Assemble the surgical ratchet wrench and tighten until the desired depth is reached.

Using the universal surgical instrument
The surgical universal instrument may be used in the superior zone of the front maxilla to control and guide the insertion of Axiom® BL while respecting the implant axis.

Please note
No tightening torque control. However, it is possible to evaluate the torque using the surgical dynamometric ratchet wrench Ref. INCCDC. Be careful not apply excessive forces to the connection. Do not hesitate to unscrew and re- screw during the implant’s insertion to reduce screwing forces.

SUBCRESTAL IMPLANT POSITIONING
The surgical protocol for the Axiom® Multi Level® implant system is including a « 0.5 mm standard subcrestal implant positioning in standard protocol».

Please note
Drilling depth = length of implant + 1 mm (0.5 mm apical reserve + 0.5 mm below the crest).

POSITIONING OF THE IMPLANT
The tightening keys and mandrels are graduated in order to ease the vertical positioning of the implant in case of flapless surgery

SUBCRESTAL POSITIONING OF THE IMPLANT CAN BE ADAPTED

• In cases of thin gingiva, the positioning of the implant can be adapted.
• It is recommended to increase the apical position of the implant in bone to anticipate the forming of new biological space.

ORIENTATION OF THE IMPLANT
The three-lobed connection indexing system allows three positions for the prosthetic components. This particular design allows for reduced handling time and the risk of confusion.

ANTICIPATE THE ORIENTATION OF THE PROSTHETIC PARTS

• The implant orientation is a key phase. It pre-determines the final orientation of the prosthetic components.
• After osteointegration and bone maturation, the position of the implant is definitive. Therefore, it is critical that the prosthetic treatment plan be established before the operation, particularly when the use of angled prosthetics is planned (for example, in case of implantary axis correction).
• Sterilisable try-in abutments are available and can be used during the surgery to check and validate the final positioning of the implant.

ORIENTATION OF THE IMPLANT

• The tightening wrenches and mandrels have 3 faces, each equipped with a visual identifier corresponding to a side of the three-lobed connection.
• At the end of screwing, orientate one of the identifier on the surfaces of the instrument as closely as possible in the appropriate direction depending on the desired prosthetic restoration and situation in the mouth.

Closing the Axiom® BL X3 implant

Indication

• Closing of Axiom® BL X3 implant with cover screw or healing screw.
• Control the drilling depth
• Cover and healing screws are delivered Q for single use.

EQUIPMENT REQUIRED

COVER SCREW
The cover screw is delivered with each Axiom® BL X3 implant. It is only available in one design. OPIM100

HEALING SCREW HEALING SCREW (DIA./ REFERENCE HEIGHT) Ht. 0.75 Ht. 1.5 Ht. 2.5 Ht. 3.5

• Choose the healing screw from among 5 available gingival heights (0.75, 1.5, 2.5, 3.5, and 4.5 mm), 4 emergence profile diameters (3.4 / 4.0 / 5.0 / 6.0 mm) and 2 possible cornal heights.
• For details, see the following table with emergence profiles as a function of the restoration.
• The laser markings present on the head of the healing screws identify the diameter (4/5/6), the gingival height (line), and whether it is a high or flat (F) version.

POSITIONING THE HEALING SCREW AND SUTURING

Note
Do not use rotating power tools to screw/unscrew prosthetic components.

PROSTHETIC DIAMETER ADAPTED TO THE SIZE OF THE TOOTH TO RESTORE

Source: Lavergne,  Paris, vol 1, serie XIII, 1974, 351-355. Legend

• 1st choice
• another possibility

Preparation of prosthetic site

Indications
Preparation of the bone crest to allow the placement of prosthetic parts on Axiom® BL X3 implants in cases of excess bone such as

• Deeply embedded Axiom® BL X3 implants
• Angulated Axiom® BL X3 implants
• Irregular alveolar crest

Features

• Delivered non sterile.
• The bur comes with a guiding pin to secure the milling axis and protect the implant connection platform.
• The burs should be used with external irrigation.
• Operating speed: 50 rpm.

CHOICE OF BUR
The burs are available in 3 diameters (Ø4.5, 5.3 and 6.6 mm). They are to be used with a guiding pin (identical for all burs). The bur should be selected according to the abutment to be placed, refer to the following table

Note
Ensure that the primary stability of the Axiom® BL implants is sufficient before using the cou.

MATERIAL REQUIRED

PROTOCOL
For all the steps of Axiom® BL X3 implant placement, refer to the protocol.

• Remove the cover screw or the healing screw, if applicable.
• Insert the pin using the User Guide surgical wrench (Manual moderate tightening <10 N.cm)*.
• Connect the countersink to the contra-angle. Without rotating it, insert the countersink into the guiding pin.
• Start the rotation of the cutting tool at 50 rpm under heavy irrigation and remove the bone volume.

Please note
Throughout the entire rotation, take care to maintain the alignment axis of the bur and the pin: do not exert any bending force on the tool.

• The window on the countersink allows you to visualise when the bur has reached the desired depth.
• Stop the rotation of the bur and remove it from the pin. Unscrew the guiding pin.
• Position the abutment in the implant.
• Within the context of 2-stage surgery, the use of hexagonal prosthesis wrenches (ref. INCHECV, INCHELV and INCHEXLV) is possible.

Implantology peripherals

Drills stops kit

Indication
Control the drilling depth.

Features

• The standard drill stop kit (Ref. INKITOPDS) includes 12 drill stops for size S drills and 24 drill stops for size L drills, so 36 drill stops for use during the placement of Axiom® implants dimensioned from Ø3.4 to Ø5.2mm.
• The complete drill stop kit (Ref. INKITOPDSL) includes 18 drill stops for size S drills and 24 drill stops for size L drills, so 42 stops for use during the placement of Axiom® implants dimensioned from Ø3.4 to Ø6.4mm.

IDENTIFY THE DRILL STOP AND UNLOCK KIT FOR ACCESS DRILL STOP

The S stops are identified by a circumferential groove; they are only mounted on S drills.  The L stops are only mounted on L drills.

ASSEMBLING THE STOPS ON THE DRILLS

Every stop is color-coded for easy identification corresponding to the diameter of the drill and the length corresponds to the drilling depth.

• Application of the stop is made directly at a counter-angle.
• Check that the stop is placed against the drill shoulder.

CHECK THE DEPTH OF THE DRILL HOLE

• Example : Axiom® stop placement—length 10 mm.

LOCK THE KIT AFTER USE

REMOVE THE STOP AFTER USE, USING THE DEVICE INCLUDED IN THE KIT

MG implant pre-positioning system

Indication
Facilitate mesio-distal placement of implants.

Features

• delivered non sterile.
• The MG solution consists of a pointer drill, 2 centring rings and a drilling guide.
• Operating speed of the pointer drill: 1500 rpm.
• The system components are used under external irrigation.

Description
The MG system facilitates the mesio-distal placement of implants by means of a pointer drill equipped with a shoulder compatible with:

• rings, allowing precise pre-positioning of an implant relative to an adjacent tooth.
• a drilling guide, equipped with a 2 in 1 rod, allowing the precise pre-positioning of an implant relative to a Ø2.0 mm drill hole or another Axiom® BL implant.

Note
The pointer drill is not recommended for use without a ring or drilling guide.

USE OF THE RINGS

Indication
Facilitate the implant pre-positioning relative to an adjacent tooth in the premolar and molar sectors. CHOICE OF RING

• The rings are available in 2 diameters (8 and 10 mm), to allow pilot drilling at 4 and 5 mm from an adjacent tooth respectively.
• The diameter of the rings is indicated on the upper side of the ring.

Ring diameters are selected in accordance with tooth center distances in accordance with J. Unger, M. Thiry (2010).

PROTOCOL

• Insert the ring in the pointer drill. Check that it is held securely in the drill.
• Press against the tooth and drive it into the bone at 1500 rpm.

The maximum depth of penetration of the pointer drill into the bone is 4 mm. Complete the drilling sequence in accordance with the implant to be placed.

USE OF THE DRILLING GUIDE

Indication
Facilitate the implant pre-positionning relative to another implant, by centring either in the initial Ø2.0 mm drill hole or in the implant itself, in case of an Axiom® BL implant.

PROTOCOL

• The drilling guide is reversible: i nsert the 2 in 1 rod into a Ø2.0 mm drill hole or an Axiom® BL implant.
• Insert the pointer drill into one of the 3 housings according to the desired inter-implant distance (8, 9, 10 mm), as indicated on the drilling guide.

Drive into the bone at 1500 rpm.

• In this configuration, the pointer drill does not have a stop: the maximum depth of pilot drilling is 5 mm.
• Complete the drilling sequence in accordance with the implant to be placed.

Please note
The drilling guide is not compatible with Axiom® TL implants. Using the guide for Axiom® TL implants could damage the internal connection of the implant.

Dual function depth gau ge

MEASURING SOCKET OR DRILLING DEPTH

1. To assess the depth of the chamber or drill hole.
2. The markings on the gauge correspond to the available implant lengths Axiom® Level x3: 6.5/8/10/12/14/16/18 mm.
3. This optional angled depth gauge can be useful to
4. Palpate the bottom of the socket (blunt tip) for immediate post extraction implant placement. 3 Check the drilling depth after using the 2.0 mm starter drill (Axiom® BL/TL/2.8 implants). USING THE DEPTH GAUGE WITH THE AXIOM® BL IMPLANT
5. The calibrated grooves correspond to the gingival heights in the Axiom® BL range: 0.75/1.5/2.5/3.5/4.5 mm.
6. Place the gauge in contact with the implant cone in order to assess the height of the soft tissue. This measuring instrument does not require connecting the implant due to its cylindrical shape.

Protocole with osteotomy technique

• Osteotomes can be used to prepare the site and implement the Axiom® BL implants.
• The OSTEO SAFE® solution is designed for crestal sinus lifts and/or maxilla bone condensation in low density bone.
• You will also find other information about how to use OSTEO SAFE® in the osteotome user guide. (063OSTEOTOMIE_NOT)
• Research code for the ifu.anthogyr.com web-sit: INUSI.

Angled drill guide for complete dental restoration using a limited number of implants

• The angled drill guide (Ref. INGFA) is the guiding tool to achieve complete screw-retained dental restoration using a limited number of implants.
• Hereunder is the detailed protocol for bone preparation and placement of the prosthetic components using the angled drill guide (Ref. INGFA).

MANDIBLE PREPARATION: DRILL SEQUENCE

DRILL GUIDE POSITIONING

• Make an incision and raise a flap.
• Make a midline osteotomy about 10 mm deep using a 2.0 mm twist drill.
• Insert the drill guide rod into the hole. Maximal blockage can be achieved using the long hexagonal wrench (Ref. INCHELV).

POSTERIOR SITE PREPARATION AND IMPLANT PLACEMENT

• Identify the chin foramen and the inferior dental nerve to avoid accidental injury.
• Using the drill guide, mark the position of the drill hole with the round bur or the pointer drill.
• The oblique lines on each end of the drill guide indicate a 30°orientation (Figure A).
• Orient the drill using the guide and drill according to the drilling sequence as defined on p.9.
• Screw the implants into the prepared holes with the three-lobes properly positioned relative to the prosthetic restoration.

ANTERIOR SITE PREPARATION AND IMPLANT PLACEMENT

• The two anterior drill holes should be as far apart as possible. However, be careful to allow for a safety distance between the apex of the anterior and posterior implants.
• Hold the drill parallel to the vertical line on the drill guide, and mark the position of the drill hole using the round bur or the pointer drill.
• Using the drill guide, mark the position of the drill hole with the round bur or the pointer drill.
• Drill according to the drilling sequence as defined on p.9.
• Screw the implants into the prepared holes with the three-lobes properly positioned relative to the prosthetic restoration.

INITIAL IMPLANT STABILITY

• Assess implant stability before placing the conical abutments or inLink® abutments on Axiom® BL implants.

MAXILLA PREPARATION: DRILL SEQUENCE

DRILL GUIDE POSITIONING

• Make an incision and raise a flap.
• Make a midline osteotomy about 10 mm deep using a 2.0 mm twist drill.
• Insert the drill guide rod into the hole.

POSTERIOR SITE PREPARATION AND IMPLANT PLACEMENT

• The anterior wall of the maxillary sinus must be identified to avoid penetration.
• Using the drill guide, mark the position of the drill hole with the round bur or the pointer drill.
• The oblique lines on each end of the drill guide indicate a 30°orientation (Figure B).
• Hold the 2.0 mm drill parallel to the oblique line and start drilling.
• Orient the drill using the guide and drill according to the drilling sequence as defined on p.9.
• Screw the implants into the prepared holes with the three-lobes properly positioned relative to the prosthetic restoration.

ANTERIOR SITE PREPARATION AND IMPLANT PLACEMENT

• The two anterior drill holes should be as far apart as possible. However, be careful to allow for a safety distance between the apex of the anterior and posterior implants.
• Hold the drill parallel to the vertical line on the drill guide, and mark the position of the drill hole using the round bur or the pointer drill.
• Drill according to the drilling sequence as defined on p.9.
• Screw the implants into the prepared holes with the three-lobes properly positioned relative to the prosthetic restoration.

INITIAL IMPLANT STABILITY
Assess implant stability before placing the conical abutments or inLink® abutments on Axiom® BL implants.

Cleaning and sterilisation

• To clean and sterilize Anthogyr components, please refer to the sterilization manual (063NETT-STE_NOT).
• Research code for the ifu.anthogyr.com web-site: INMODOPS3.

Disassembling – Re-assembly
The assembly and disassembly operations of the Anthogyr kits and ratchet wrench (Ref. INCC) are described in the sterilization manual (063NETT- STE_NOT). Research code for the ifu.anthogyr.com web-site: INMODOPS3.

For all other Anthogyr devices, please refer to their respective instructions for use.

Component reference numbers

Axiom® BL X3

Healing

• Reference number for represented component
• These tools are not supplied in the kit INMODOPS3

Surgical instruments

DRILLS

MANDRELS AND WRENCHES AXIOM®

ACCESSORIES OF SURGERY D. KITS

INMODOPS3V
–| Empty Axiom ® Multi Level ® L surgical kit| INMODOPS3LV
**–| Update kit OPS3 — > OPS3L| ****PACKUPOPS3L
Includes:
– 1 empty L Axiom® Multi Level® surgical kit
– 1 step drill Ø4.8 / 5.4 S
– 1 step drill Ø5.4 / 6.0 S
****–| Update kit OPS3 – > OPS3L| KITUPOPS3L**
Includes:
– 1 storage plate 3/4
– 1 step drill Ø4.8 / 5.4 S
– 1 step drill Ø5.4 / 6.0 S
– 2 adjustment grommets

Anthogyr

• 2 237, Avenue André Lasquin 74700 Sallanches – France
• Tél. +33 (0)4 50 58 02 37
• www.anthogyr.com
• Photos credits: Anthogyr – All rights reserved – Not contractual photos

References

• Anthogyr, Instructions For Use

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