DENTCA Denture Teeth

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General Information

The DENTCA Denture Teeth resin is an FDA cleared biocompatible photocurable material. Performance and strength are the same as conventional acrylic. This resin is apart of SprintRay's Open Certified Resin system. 

 

Use Case(s)

DENTCA Denture Teeth is a good resin choice for 3D printed removable dentures. To obtain the guaranteed results this resin is to be used in conjunction with DENTCA Denture Base II resin

 

 

DENTCA Denture Teeth Shades:

  • A1
  • A2
  • A3
  • A3.5
  • B1
  • B2

 

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Instructions For Use


Prescription Use Statement
Caution: Federal law restricts this device to sale by or on the order of dentist or any other practitioner
licensed by the law of the State in which he/she practices to us or order the use of the device.

Indications for Use

DENTCA Denture Teeth is a light-curable polymerizable resin to fabricate, by additive manufacturing,
preformed denture teeth to be used in a denture. The fabricated tooth is an alternative to preformed
plastic tooth for denture.


The fabrication of denture tooth with DENTCA Denture Teeth requires digital denture tooth files instead
of physical molds, a stereolithographic additive printer, and curing light equipment.

  1. Digital denture teeth file; STL format file
  2. Stereolithographic additive printer and its operation software;
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  3. Curing light equipment
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Specific Manufacturing Considerations

  1. Digital denture tooth file
    1. File format: STL file
    2. Digital design: DENTCA BYTE tooth – Universal, Oval, and Square
    3. File size should be upload-able in the 3D printer operation software.
  2. Stereolithographic additive printer
    1. Hardware
      1. Laser wavelength: 385 nm or 405 nm
      2. Light source
        ▪ Stereolithographic (SLA) method; laser with 25 mW < X < 250 mW
        ▪ Digital Light Processing (DLP) method; high power LED or lasers
      3. Build Volume: > 70 x 50 x 150 cm (Least fit one arch)
      4. Laser spot size (XY resolution): < 160 micron
      5. Build Speed: 1 – 1.5 cm/hr at 50 micron and 1.5 - 4 cm/hr at 100 micron
      6. Build Path: line drawing path or surface layer drawing path
    2. Features of Operations Software
      1. STL File Import
      2. Automatic Rotation and Placement
      3. Layer Slice for path inspection
      4. Auto and manual generation of supports
    3. Printing Parametersmceclip0.png
    4. Environmental Conditions
      1. Temperature: 18-30°C
      2. Relative Humidity: 30-90%
    5. Cleaning Kit
      1. Rinse bath and tubs, flush cutter, paper towels, squeeze bottle for IPA, Scraper
    6. Recommended Printer
      1. Zenith U Printer, MoonRay S100 and SprintRay Pro Printers, Asiga Max, Pro2 and Pro 4K Printers, Ackuretta DENTIQ (formerly known as FreeShape 120) and SOL Printers, WhipMix VeriBuild and VeriEKO Printers
  3. Recommended Curing light equipment (Post Curing Units)
    1. Flood Type Curing Equipmentimage.png
    2. Accessories
      1. USP Grade Glycerin
      2. Transparent glass container and 2 glass plates
      3. Heat protective gloves and silicone coated stainless steep tong
      4. thermocouple
  4. Notification
    1. 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.

Warnings:


DENTCA Denture Teeth contains polymerizable monomers which may cause skin irritation (allergic contact dermatitis) or other allergic reactions in susceptible persons. If contact with skin, wash thoroughly with soap and water. If skin sensitization occurs, discontinue use. If dermatitis or other symptoms persist, seek medical assistance. Avoid inhalation or ingestion. High vapor concentration can cause headache, irritation of eyes or respiratory system. Direct contact with eyes may cause possible corneal damage. Long-term excessive exposure to the material may cause more serious health effects. Monitor air quality per OSHA standards.


Eye Contact: Immediately flush eyes with plenty of clean water for at least 20 minutes, and consult a physician. Wash the contacted area thoroughly with soap and water.

Inhalation: In case of exposure to a high concentration of vapor or mist, remove person to fresh air. Give oxygen or artificial respiration as required.


Ingestion: Contact your regional poison control center immediately.


BURN HAZARD: GLYCEROL BATH CAN REACH TEMPERATURES OF 90 oC (~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.

 

Precautions:

  1. When washing the printed denture teeth with solvent or grinding the denture teeth, it should be in a properly ventilated environment with proper protective masks and gloves
  2. Store DETCA Denture Teeth at 15 -25°C(60 - 77°F) and avoid direct sunlight. Keep container closed when it is not in use. Product shall not be used after expiration date.
  3. Expired or unused DENTCA Denture Teeth should be completely cured or polymerized prior to disposal

 

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 denture base resins as the particulate generated during grinding may cause respiratory, skin, or eye irritation

Procedure to Fabricate Teeth


Printing Preparation

  1. Select the denture tooth shade based on prescription. (Recommended to use the
    different resin tank for the different shade.)
  2. Open the 3D printer cover and fill the resin tank of the printer with fresh DENTCA
    Denture Teeth up to the required filling line by manufacturer. (When filling the resin
    into the resin tank, gloves and mask should be used.)
  3. Close the printer cover.

 

Printing

  1. Load the denture base model file to be printed in printer operation software which
    printer manufacturer recommended.
  2. Use the software tool to rotate the teeth in order to face the root part of teeth to the build
    plate form.
  3. Tilt the lingual side and root of teeth to around 20 to 40 degree against the build plate form.
  4. Generate support sticks on the denture teeth using the recommended setting by printer
    provider. If the support is not enough, add supports on the teeth. (Avoid the support
    structures on the valley between teeth.)
  5. Use layout tools to move the denture teeth to be evenly distributed
  6. Start printing.

Cleaning

  1. Detach the printed denture teeth from the build platform.
  2. Use a small flush cutter to remove the support sticks from the denture teeth.
  3. Wash the denture base with isopropyl alcohol.
  4. Use air blowing to dry the denture teeth or dry it at room temperature under ventilation
    system or open area.

Teeth Post Curing

  1. Smooth the support marks using a bur after washing the teeth with water and drying. 
  2. For printed denture fabrication, skip this post-curing step and move to “Denture Fabrication
    using a printed teeth and base” step.
    For conventional fabrication to use as preformed teeth, the printed teeth should be cured
    by soaking into glycerin container for the required curing time under recommended post curing unit.
  3. Use the printed preformed teeth to fabricate a denture by conventional denture process.

 

Denture Fabrication using a printed denture teeth and base


Bonding the printed teeth to the printed denture base

  1. Prepare, before post-cured, the printed teeth and printed denture base with socket shapes
    to receive printed teeth (Tooth Sockets).
  2. Place the printed teeth with DENTCA Denture Teeth into the corresponding Tooth Sockets
    on the printed denture base and check teeth fitting
  3. Apply small amount of light curable adhesive into the Tooth Sockets and bond the teeth by
    exposing into UV light until the teeth is set in position. Recommend using DENTCA Denture
    Base II for bonding.
  4. If necessary, apply small amount of DENTCA Denture Base II using an applicator to
    smoothen the edges of the denture base and cure it.
  5. Add denture base material 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

  1. Cure the final denture by sinking into the glycerin container (glycerin temperature should be
    greater than 60°C and it is recommended to be replaced every 80 hrs of running or every
    three months whichever comes first.) for the required curing time under recommended
    post-curing unit. For half of the post-curing time tissue shall side up and for another half of
    the time tissue shall side down. (For Dentalfarm PHOTOPOL A5408D, pre-heating the curing
    unit with glycerin for 2 hours before post-curing is required.)
  2. Take out the printed denture from the curing oven using coated tong (Be careful of hot glycerin!).
  3. Rinse the cured denture with a water.



Finishing

  1. Smoothen the support spots on the denture base using a bur.
  2. Polish the final denture with wet polishing sand by conventional method.

Repair of denture and baseplates


Note: This process is only applied to 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. Prepare the fracture area by grinding to open more and roughing the outer side of fracture area.
  3. Prime the roughened surfaces of the repair area with DENTCA Denture Base II.
  4. Place the broken denture on the cast.
  5. Apply the DENTCA Denture Base II resin to cover the roughed and fracture areas and cure the areas by exposing light curing machine until the resin is solidified.
  6. Place the denture on the cast in the post-curing machine for the half of required time. Carefully remove the denture from the cast and cure the tissue side for the half of required time.
  7. Grind, polish and finish.





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