formlabs PRNT-107232 Denture Base Resin Instruction Manual

form labs PRNT-107232 Tooth Base Resin

Denture Base Resin

The following Instructions For Use are for Formlabs biocompatible photopolymer Denture Base Resin. Basic information about safety and environmental concerns is also included. For more detailed safety and environment information please refer to the Safety Data Sheet, available at dental. formlabs. com. For further information regarding the use of the material, please contact Formlabs.

Introduction And Indications For Use

INDICATIONS FOR USE
Denture Base Resin is a light-curable resin indicated for the fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto-polymerizing resins. Fabrication of dental prosthetics with Denture Base Resin requires a computer- aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, stereolithographic additive printer, and curing light equipment.

Specific Manufacturing Considerations

NOTIFICATION
The device specifications have been validated using the software, printers, and process parameters specified in this document. Any other printers, operation software and post-printing processes will be outside of the device specifications and the FDA clearance. Users shall follow this document to use the device. If there is any serious incident (death or permanent damage to a patient) that has occurred with this device, please report it to Formlabs ([email protected]) or your local authority of medical devices. If you receive damaged or unintentionally opened bottles before use, or if the packaging is exposed to environmental conditions outside of those specified on the label, please inform Formlabs (support formlabs.com).

REQUIREMENTS
Use dedicated accessories for Denture Base Resin. For biocompatibility, Denture Base Resin requires a dedicated resin tank, build platform, Form Wash, and finishing kit, which should not be mixed with any other resins.

RECOMMENDED 3D PRINTER AND PRINTING PARAMETERS

• Hardware: Formlabs SLA 3D printer
  • Optical wavelength: 405 nm
  • Z-axis layer thickness: 50 μm
  • Build volume: > 70 x 50 x 150 cm (at least fit one arch)
  • Optical spot size (XY resolution): < 160 μm
• Software: Formlabs PreForm
  • STL file import
  • Manual/Automatic rotation and placement
  • Layer slicer for path inspection
  • Auto-mesh repair
  • Manual/Automatic generation of supports
• Printing Parameters
  • Layer thickness: 50 μm
  • Optimal orientation: 20° – 40° tilted orientation
  • Support point size: 0.4 – 1.0 mm
  • Support density: 0.7 – 1.5
  • Digital denture base file; STL format file with the following minimum thickness of the area
• Recommended Post-Processing Equipment:
  • Formlabs Form Wash or Formlabs Form Wash (2nd Generation)
  • Isopropyl alcohol (IPA) ≥ 90%
  • Formlabs Form Cure or Formlabs Fast Cure
  • USP grade glycerol (≥ 99.5% purity, CAS# 56-81-5)
  • Transparent glass container (recommend Pyrex* Basics 23oz dish: 6” x 6” x 2.5”)
• Environmental Conditions:
  • Temperature: 18 – 30 °C
  • Relative Humidity: 30 – 90 %

Hazards And Precautions

WARNINGS

1. Denture Base Resin contains polymerizable monomers which may cause skin irritation (allergic contact dermatitis) or other allergic reactions in susceptible persons. If resin contacts the skin, wash thoroughly with soap and water. If skin sensitization occurs, discontinue use. If dermatitis or other symptoms persist, seek medical assistance.
2. Avoid inhalation or ingestion. High vapour concentration can cause headaches and irritation of the eyes or respiratory system. Direct contact with the eyes may cause possible corneal damage. Long-term excessive exposure to the material may cause more serious health effects. Specifically, it is not suitable for pregnant or breastfeeding women. Monitor air quality per OSHA standards.
3. BURN HAZARD: GLYCEROL BATH CAN REACH TEMPERATURES OF 90°C (~200°F) AND LEAD TO SEVERE BURNS. Only trained users should perform the glycerol curing step with caution and appropriate PPE. We also recommend placing a warning label on the window of the cure unit to alert all lab users to the potential hazard.
4. Eye contact: Immediately flush your eyes with plenty of clear water for at least 20 minutes, and consult a physician. Wash the contacted area thoroughly with soap and water.
5. Inhalation: In case of exposure to a high concentration of vapour or mist, remove the person from fresh air. Give oxygen or artificial respiration as required.
6. Ingestion: Contact your regional Poison Control Center.

PRECAUTIONS

1. When washing the printed part with isopropanol or grinding the denture bases, it should be in a properly ventilated environment with proper protective masks and gloves.
2. Store Denture Base Resin at or below 15 – 25°C (60 – 70 °F) and avoid direct sunlight. Keep the container closed when it is not in use. The product shall not be used after the expiration date.
3. Expired or unused Denture Base Resin should be completely cured or polymerized before disposal. Glycerol and isopropanol shall be disposed of by local regulations.

ADVERSE REACTIONS

1. Direct contact with the uncured resin may induce skin sensitization in susceptible individuals.
2. Proper ventilation and personal protective equipment should be used when grinding the denture base as the particulate generated during grinding may cause respiratory, skin and eye irritation.

Procedure To Fabricate Dentures

PRINTING AND POST-PROCESSING

1. Select the Denture Base Resin shade based on the prescription. Note: Use a dedicated resin tank for different shades.
2. Shake cartridge: Before use, shake the cartridge well. Colour deviations and print failures may occur if the cartridge is shaken insufficiently.
3. Set up: Insert resin cartridge into a compatible Formlabs 3D printer.
4. Printing:
   • Prepare a print job using PreForm software. Import the denture base STL file. Orient and generate support.
   • For recommendations on print orientation and support placement, see the detailed application guide at dental.formlabs.com.
   • Send a print job to the printer. Begin print by selecting a print job from the print menu. Follow any prompts or dialogues shown on the printer screen.
   • The printer will automatically complete the print.
5. Part removal:
   • Remove the build platform from the printer.
   • Printed parts can be removed from the build platform before or after cleaning in a Form Wash.
   • To remove, wedge the part removal tool under the printed part, and rotate the tool. For detailed techniques visit support.formlabs.com.
6. Rinsing: Wash the printed parts in IPA using a Formlabs Form Wash for 10-20 minutes.
7. Drying:
   • Remove parts from IPA and either leave to air dry at room temperature or dry using a source of compressed air.
   • Inspect parts to ensure that the denture bases are fully washed and dried with no particles or residues before proceeding to subsequent steps.
8. Support removal:
   • Remove supports using a cutting disk and handpiece, or with other part removal tools.
   • Carefully smoothen the supported surfaces of the denture base using a bur and handpiece.
   • Attention: Do not post-cure printed denture bases before bonding with denture teeth.

DENTURE FABRICATION USING PRINTED DENTURE BASE AND TEETH

1. Bonding denture teeth to denture base:
   • Before post-curing, remove any material from the teeth and tooth sockets on the denture base, which may impede tooth placement.
   • Place the printed teeth with Denture Teeth Resin into the corresponding tooth sockets on the printed denture base and check teeth fitting.
   • Remove the teeth to prepare for bonding.
   • Apply a small amount of Denture Base Resin to the tooth sockets using a brush, press the teeth into the corresponding socket and hold them firmly in place.
   • Tack the teeth into place using a handheld UV-light source, applying light to both the lingual and buccal/facial surfaces.
   • If necessary, apply a small amount of Denture Base Resin to the interproximal surfaces or elsewhere to ensure a smooth, complete bond between the teeth and base.
   • Repeat the above steps until all teeth are bonded to the denture base. Check the occlusion of the assembled denture against the opposing denture/model before post-curing.
   • Add Denture Base Resin manually on the lingual ridge area to thicken and cure it. It is recommended to make it thicker than 4.0mm for maxillary and 4.5mm for mandibular.

Post-curing with Form Cure
Attention: Only post-cure the denture base after fully assembling with the denture teeth.

• Fill a glass container with glycerol, and place it on the turntable inside a Form Cure. 6” diameter Pyrex* containers are recommended.
• Set the Form Cure temperature to 80°C and wait for 2 hours until glycerol fully warms up.
• Place the assembled denture in the glycerol, ensuring that it is fully submerged.
• Cure for 30 minutes at 80°C.
• Flip the assembled denture and cure for an additional 30 minutes at 80°C.
  Note: Replace glycerin after 80 hours of use or every three months whichever comes first.

Post-curing with Fast Cure
Attention: Only post-cure the denture base after fully assembling with the denture teeth.

• Fill a glass container with glycerol. 6” diameter Pyrex*containers are recommended.
• Place the assembled denture in the glycerol, ensuring that it is fully submerged.
• Place the glycerol container containing the assembled denture on the turntable inside a Fast Cure.
• Cure for 3 minutes at light intensity level 7.
• Flip the assembled denture and cure for an additional 3 minutes at light intensity level 7. 3.

Finishing

• Polish the final denture using conventional methods as for traditional dentures.
• It isrecommended to wet polish using a rag wheel and pumice, using low speeds initially to smoothen the surfaces without removing characterization, followed by a quick polish at high speeds using acrylic high-shines.

REPAIRING DENTURES AND BASEPLATES

Note
This process only applies in temporary repair cases. It is recommended to remake the whole denture using an original design file.

1. Prepare a cast made of a putty using a broken denture.
2. Grind the fracture area using a handpiece bur to roughen the surfaces and open the fracture slightly more.
3. Prime the roughened surfaces with Denture Base Resin. Place the broken denture on the cast and fill the roughed and fractured area with Denture Base Resin.
4. Cure the areas by exposing them to UV light until the resin is solidified.
5. Place the denture on the cast in a Form Cure, and cure for 30 minutes. Carefully remove the denture from the cast and cure the tissue side (intaglio surface) for 30 minutes.
6. Alternatively, place the denture on the cast in a Fast Cure, and cure for 3 minutes at light intensity level 7. Carefully remove the denture from the cast and cure the tissue side (intaglio surface) for 3 minutes at light intensity level 7.
7. Finish the repaired denture using conventional methods.

References

• High Resolution SLA 3D Printers for Dental Professionals | Formlabs Dental
• High Resolution SLA and SLS 3D Printers for Professionals | Formlabs
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