Prosthetic devices · 21 CFR 872 Subpart D
Resin Denture Tooth Preformed Additively Manufactured
For the fabrication of preformed denture teeth for use in a denture base
- Companies listing it
- 4335 makers
- Brands and models
- 127
- 510(k) clearances
- 10 in five years
- FDA name
- Additively Manufactured, Preformed, Resin Denture Tooth
510(k) clearances per year, 1976–2026
Companies that list PZY
43 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | Lucitone Digital Print for Primeprint | 148 | 2026 |
| Prismatik Dentalcraft, Inc. | United States | Maker | Glidewell 3DP Denture Teeth Resin Shade A1 · Glidewell 3DP Denture Teeth Resin Shade A2 · Glidewell 3DP Denture Teeth Resin Shade A3 · Glidewell 3DP Denture Teeth Resin Shade A3.5 · +11 | 56 | 2026 |
| Aidite (Qinhuangdao) Technology Co., Ltd | China | Maker | Additive Manufacturing (Light Curing) Crown Bridge Resin | 16 | 2026 |
| SprintRay Inc. | United States | Maker | Apex Teeth (A1, A2, B1, Bleach) · Crown HT (A1, A2, A3, B1, Unpigmented, Bleach) · High Impact Denture Teeth (Bleach, A1, A2, A3, B1) · NanoCeramic Hybrid OnX (Bleach, A1, B1) · +3 | 8 | 2026 |
| Kulzer, LLC | United States | Maker | dima Print Teeth · dima Print Teeth & Temp | 37 | 2026 |
| Hangzhou SHINING3D Dental Technology Co., Ltd | China | Maker | CB11-A1 · CB11-A2 · CB11-A3 · CB11-A3.5 · +6 | 6 | 2026 |
| Deltamed GmbH | Germany | Maker | PRO Resins Arch X · PRO Resins Tooth X · RS VIVO C&B Ultimate · 3Delta Denture Teeth · +1 | 6 | 2024 |
| Saremco Dental AG | Switzerland | Maker | saremco print Crowntec | 4 | 2025 |
| Blue Sky Bio, LLC | United States | Maker | Blue Sky Plan - Denture Module | 20 | 2024 |
| Guangzhou Heygears IMC., Inc. | China | Maker | UltraPrint Denture Teeth UV | 3 | 2026 |
| Zirkonzahn Srl | Italy | Maker | — | 10 | 2023 |
| Vertex-Dental B.V. | Netherlands | Maker | NextDent Jet Base · NextDent Jet Teeth · Saremco Print Crowntec | 7 | 2024 |
| Dentca, Inc. | United States | Maker | DENTCA Denture Teeth | 6 | 2026 |
| Detax GmbH | Germany | Maker | FREEPRINT crown A3,5 1000g · FREEPRINT crown A3,5 500g · VITA VIONIC® DENT RESIN 0M3 1000g · VITA VIONIC® DENT RESIN 0M3 500g · +16 | 2 | 2025 |
| Formlabs Inc. | United States | Maker | Premium Teeth Resin | 2 | 2026 |
| Asiga | Australia | Maker | DentaTOOTH | 2 | 2025 |
| DIO Corporation | South Korea | Maker | DIOnavi-P. MAX · DIOnavi. C&B · DIOnavi. C&B Z | 14 | 2023 |
| Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | Brazil | Maker | SMART PRINT BIO VITALITY A2 · SMART PRINT BIO VITALITY A2-HT · SMART PRINT BIO VITALITY A3 · SMART PRINT BIO VITALITY A3-HT · +4 | 1 | 2026 |
| Riton 3D Technology Co., Ltd | China | Maker | Denture Teeth Model DT1-A1 · Denture Teeth Model DT1-A2 · Denture Teeth Model DT1-A3 | 1 | 2024 |
| Dental Manufacturing S.p.A. | Italy | Maker | ACRY NATURE AFG 6 LOWER · ACRY NATURE AFG 6 UPPER · ACRY NATURE AFG 8 LOWER · ACRY NATURE AFG 8 UPPER · +8 | 1 | 2026 |
| Stratasys Ltd | Israel | Maker | TrueDent Clear · TrueDent Cyan · TrueDent Magenta · TrueDent White · +1 | 1 | 2022 |
| Shenzhen Piocreat 3D Technology Co., Ltd | China | Maker | Denture Base Resin(PN-Denture (Red,White)) | 1 | 2024 |
| Cavex Holland BV | Netherlands | Maker | Cavex Instant Stone | 26 | 2015 |
| Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | Germany | Maker | VarseoSmile Teeth · VarseoSmile TriniQ | 4 | 2013 |
| pro3dure medical GmbH | Germany | Maker | ACRY Print RU-001 temporary · FLOW C&B · GR-17 temporary · GR-17.1 temporary lt; Structomer Temps | 2 | 2021 |
| The Myerson Company Limited | Trinidad & Tobago | Maker | Trusana · Trusana1 | 1 | 2017 |
| one day dental partner | South Korea | Maker | kage Additively manufactured, preformed, resin denture tooth-print | — | — |
| Suzhou laixin 3D Technology Co.,Ltd | China | Maker | Dental Teeth (A1,A2,A3,A3.5,B1,B2,B3,Bleach,C2) · Dental Teeth Plus (A1,A2,A3,A3.5,B1,B2,B3,Bleach,C2) · Print teeth (A1,A2,A3,A3.5,B1,B2,B3,Bleach,C2) | — | — |
| Jinyuan medical equipment(tianjin)co.,ltd | China | Maker | N/A | — | — |
| Leixir Resources Private Limited | India | Maker | Lucitone Digital Print Denture System | — | — |
| 3BFAB Teknoloji Anonim Sirketi | Türkiye | Maker | Dentafab NanoCeram | — | — |
| Shenzhen Yongchanghe Technology Co., Ltd. | China | Maker | Denture Base Resin, Temporary C&B resin | — | — |
| Xiamen Antinsky Industry Co., Ltd | China | Maker | Denture Base Resin, Temporary Dental Model Resin | — | — |
| Rite Smile Labs | China | Maker | 3d printed teeth artificial resin | — | — |
| Perfect crown dental lab | United States | Maker | — | — | — |
| Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | Germany | Manufacturer | VITA VIONIC® DENT RESIN | 8 | 2026 |
| Myerson LLC | United States | Contract manufacturer | Trusana · Trusana1 | 1 | 2023 |
| US Orthodontic Products | United States | Repacker / relabeler | — | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Manufacturer | Resin Denture Tooth | — | — |
| anaxdent North America | United States | Lister | 3Delta UNlimited | — | — |
| Universal Orthodontic Lab, Inc. | United States | Manufacturer | — | — | — |
| Shaw Dental Laboratories Corp. | United States | Repacker / relabeler | Resin Denture Tooth | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 22 Nov 2017 | K172398 | DENTCA DENTURE Teeth | Dentca, Inc. |
Official records: FDA product classification for PZY · 21 CFR 872.3590.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026