DENTCA Zenith U Denture Teeth Instructions

DENTCA Zenith U Denture Teeth

Product Information

The DENTCA Denture Teeth is a light-curable polymerizable resin used to fabricate preformed denture teeth. These teeth are an alternative to preformed plastic teeth for dentures. The fabrication process requires digital denture tooth files, a stereolithographic additive printer, and curing light equipment.

Requirements

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

Stereolithographic Additive Printer Options

Curing Light Equipment Options

Specific Manufacturing Considerations

1. Digital denture tooth file is required.
2. Stereolithographic additive printer should be used.
3. The operation software for the printer should have the following features:
   • STL file import
   • Automatic rotation and placement
   • Layer slicer for path inspection
   • Auto and manual generation of supports
4. The printing parameters vary based on the printer model. The recommended layer thickness, orientation angle, support point size, and spacing are provided in the manual.
5. A cleaning kit, including rinse bath and tubs, flush cutter, paper towel, squeeze bottle for isopropyl alcohol, and scraper, is recommended for maintenance.

Recommended Printer and Curing Light Equipment

The following printers are recommended for use with DENTCA Denture Teeth:

• 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

For post-curing, the following curing light equipment is recommended:

• Dymax/ECE 5000
• Electro-lite/ELC-4001
• Uvitron/Intelliray 600
• Uvitron/Sunray 400
• Honle UV Cure/Sol 500
• Wicked Engineering/CUREBox Plus
• SprintRay/Pro Cure

Directions for Use

The acquisition of this product for the purpose of distribution or reselling without DENTCA’s authorization is prohibited.

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.

Requirements

1. Digital denture teeth file; STL format file
2. Stereolithographic additive printer and its operation software;
   Stereolithographic additive Printer|

Operation Software

|

Provider

---|---|---
Product Name| Model
Zenith| U| Zenith| Dentis -USA
SprintRay| MoonRay S100 or

SprintRay Pro*

| Rayware| SprintRay
Asiga| Max, Pro2 or Pro

4K

| Asiga Composer| Asiga

Ackuretta

| DENTIQ (formerly known as FreeShape 120) or

SOL

|

Alpha 3D

|

Ackuretta

WhipMix| VeriBuild or

VeriEKO

| Alpha 3D| WhipMix

Orienting printing model in Z direction or vertically to the platform is not recommended due to the SprintRay Pro printer is not supportive in that direction.

3. Curing light equipment
   Curing Equipment

   Model| Provider
   ECE 5000| Dymax
   ELC 4001| Electro-lite
   UV Sol 500/UVcube| Honle
   Intelliray 600/SunRay 400| Uvitron
   CUREBox Plus| Wicked Engineering
   Pro Cure| SprintRay
   Otoflash G171| NK-Optik
   ---|---
   PHOTOPOL A5408D| Dentalfarm
   CURIE| Ackuretta

Rx only

Specific Manufacturing Considerations

1. Digital denture tooth file
2. File format: STL file
3. Digital design: DENTCA BYTE tooth – Universal, Oval, and Square
4. File size should be upload-able in the 3D printer operation software.
5. Stereolithographic additive printer
6. Hardware
7. Laser wavelength : 385 nm or 405 nm
8. Light source
9. Stereolithographic (SLA) method; laser with 25 mW < X < 250 mW
10. Digital Light Processing (DLP) method; high power LED or lasers
11. Build Volume: > 70 x 50 x 150 cm (Least fit one arch)
12. Laser spot size (XY resolution): < 160 micron
13. Build Speed: 1 – 1.5 cm/hr at 50 micron and 1.5 – 4 cm/hr at 100 micron
14. Build Path: line drawing path or surface layer drawing path
15. Features of Operation Software
16. STL file import
17. Automatic rotation and placement
18. Layer slicer for path inspection
19. Auto and manual generation of supports
20. Printing Parameter

Printer Model

| Layer Thickness

(micron)

| Recommended orientation angle (degree)| Support point size (mm)|

Support density

---|---|---|---|---
Zenith U| 50-100| 20-40| 0.4 – 1.0| 0.7 – 1.5
MoonRay S100 or SprintRay Pro| 50| 20-40| Medium| Medium
Asiga Max, Pro2 or Pro 4K| 50-100| 20-40| 0.8| Spacing 3.0mm
Ackuretta DENTIQ (formerly known as FreeShape 120) or SOL|

50-70

|

20-40

|

1.5

|

70% – 80%

---|---|---|---|---
WhipMix VeriBuild or VeriEKO| 50-70| 20-40| 1.5| 70% – 80%
4. Environmental Conditions

1. Temperature: 18 – 30 oC
2. Relative Humidity: 30 – 90 %
3. Cleaning Kit
4. Rinse bath and tubs, flush cutter, paper towel, squeeze bottle for isopropyl alcohol, Scraper
5. Recommended Printer
6. 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
7. Recommended Curing light equipment (Post curing units)
8. Flood Type Curing Equipment
   Provider/

Model

| Curing

Chamber

| Supply

Voltage

| Lamp

Power

| Light

Intensity

| Lamp

Wavelength

| Curing

Time

---|---|---|---|---|---|---
Dymax/

ECE 5000

| Required| 100 – 240

V/50 -60 Hz

| 400W| 225

mW/cm2

| UVA

(365 nm)

| 20 min
Electro-lite/

ELC-4001

| Required| 110 or

220V/65Hz

| 400W| 125

mW/cm2

| UVA + UVV

(365 nm)

| 40 min
Uvitron/ Intelliray 600|

Required

| 100, 240 V/

50 – 60 Hz

|

600 W

| 175

mW/cm2

| UVA (320-

390 nm)

| 20 min

at 50% intensity

Uvitron/Sunray 400| Required| 100, 240 V/

50 – 60 Hz

| 400W| 115

mW/cm2

| UVA (320-

390 nm)

| 20 min
Honle UV Cure/

Sol 500

| Required| 115V/60Hz| 400W| 120

mW/cm2

| UVA + UVV| 60 min
Wicked Engineering/ CUREBox Plus| Required| 100-

240VAC/50-

60Hz

| 36W| 12

mW/cm2

| UVA + UVV (365-

405nm)

| 40 min
SprintRay/ Pro Cure| Required| 110-

240VAC/50-

60Hz

| 90W| 23

mW/cm2

| UVA + UVV (365-

405nm)

| 40 min
NK-Optik/ Otoflash G171| Required| 100, 117,

230VAC/50-

60Hz

| 200W| 50

mW/cm2

| UVB + UVA

+ UVV (280-

580nm)

| 10 min
---|---|---|---|---|---|---
Dentalfarm/ PHOTOPOL A5408D| Required| 100, 117,

230VAC/50-

60Hz

| 50W| 100

mW/cm2

| UVA + UVV (350-

550nm)

| 40 min
Ackuretta/ CURIE| Required| 100-

240VAC/50-

60Hz

| 75W| 190

mW/cm2

| UVA + UVV (365-

405nm)

| 10 min (T:10, D:10,

I:13,

B:ON)

2. Accessories
  1. USP Grade glycerin
  2. Transparent glass container and 2 glass plates
  3. Heat-protective gloves and silicone coated stainless steel tong
  4. Thermocouple

4. 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.
   Warnings:

5. 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.

6. 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 oF) 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 DENTCA Denture Teeth at 15 – 25 oC (60 -77 oF) 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 printed denture teeth as the particulate generated during grinding may cause respiratory, skin or eye irritation.

Procedure to Fabricate Teeth

1. Printing Preparation

2. Select the denture teeth shade based on prescription. (Recommended to use the different resin tank or tray for the different shade.)

3. Open the 3D printer cover and fill the resin tank or tray of the printer with DENTCA Denture Teeth up to the required filling line by manufacturer. (When filling the resin into the resin tank or tray, gloves and mask should be used.)

4. Close the printer cover.

5. Printing

6. Load the denture teeth model file to be printed in printer operation software which printer manufacturer recommended.

7. Use the software tool to rotate the teeth in order to face the root part of teeth to the build plate form.

8. Tilt the lingual side and root of teeth to around 20 to 40 degree against the build plate form.

9. 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.)

10. Use layout tools to move the denture teeth to be evenly distributed.

11. Start printing.

12. Cleaning

13. 1. Detach the printed denture teeth from the build platform.

14. Use a small flush cutter to remove the support sticks from the denture teeth.

15. Wash the denture teeth with isopropyl alcohol.

16. Use air blowing to dry the denture teeth or dry it at room temperature under ventilation system or open area.

17. Teeth Post Curing

18. Smooth the support marks using a bur after washing the teeth with water and drying.

19. 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.

20. Use the printed preformed teeth to fabricate a denture by conventional denture process.

Denture Fabrication using a printed denture teeth and base

1. Bonding the printed teeth to the printed denture base
2. Prepare, before post-cured, the printed teeth and printed denture base with socket shapes to receive printed teeth (Tooth Sockets).
3. Place the printed teeth into the corresponding Tooth Sockets on the printed denture base and check teeth fitting.
4. 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.
5. If necessary, apply small amount of DENTCA Denture Base II using an applicator to smoothen the edges of the denture base and cure it.
6. Post Curing
7. Cure the final denture by sinking into the glycerin container (glycerin temperature should be greater than 60oC and it is recommended to be replaced every 80 hrs 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.)
8. Take out the printed denture from curing oven using coated tong (Be careful of hot glycerin!).
9. Rinse the cured denture with water.
10. Finishing
11. Smoothen the support spots on the denture base using a bur.
12. Polish the final denture with wet polishing sand by conventional method.

DENTCA, INC. 357 VAN NESS WAY, STE 250 TORRANCE, CA 90501, USA
ISSUED ON 12/7/2021
01-09-105-014

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