Prosthetic devices · 21 CFR 872 Subpart D
Backing and Facing Artificial Teeth
FDA device type “Teeth, Artificial, Backing And Facing”.
- Companies listing it
- 2722 makers
- Brands and models
- 37
- 510(k) clearances
- 20 in five years
- FDA name
- Teeth, Artificial, Backing And Facing
510(k) clearances per year, 1976–2026
Companies that list ELK
27 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Vertex-Dental B.V. | Netherlands | Maker | Ceramill C&B MFH · NextDent C&B · NextDent C&B MFH | 7 | 2024 |
| The Belport Company, Inc. DBA Gingi-Pak | United States | Maker | — | 2 | 2026 |
| Manufacturera Dental Continental | Mexico | Maker | ISOTEK TEETH · NEW TEK TEETH | 2 | 2001 |
| Royal Dental Laboratory | China | Maker | Veneer | 1 | 2020 |
| Zain's Medical Image | Pakistan | Maker | DENTAL CARVERS · SCALERS | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | TEETH, ARTIFICIAL, BACKING AND FACING | — | — |
| one day dental partner | South Korea | Maker | kage TEETH, ARTIFICIAL, BACKING AND FACING | — | — |
| Xplora USA LLC | United States | Maker | Lammina | — | — |
| Improve Co.,limited | Hong Kong SAR China | Maker | TEETH, ARTIFICIAL, BACKING AND FACING | — | — |
| dentona AG | Germany | Maker | optiprint I-B-T 385 · optiprint lumina | — | — |
| China Dental Outsourcing Inc | China | Maker | Cercon Zirconia · e.max · EMPRESS CROWN · EMPRESS INLAY/ONLAY · +1 | — | — |
| Cometech VN Company Limited | Vietnam | Maker | COMETECH VN | — | — |
| Foo Tian Dental Laboratory | China | Maker | Veneers or facings | — | — |
| Arak Dental Lab | United Arab Emirates | Maker | Artificial teeth | — | — |
| Jiangyin Jintaike Biotech Co., Ltd. | China | Maker | TEETH, ARTIFICIAL, BACKING AND FACING | — | — |
| Maya Villegas S.A.S. | Colombia | Maker | BIOGENIC · DURODENT · MARFIL DIENTES · RITE-DENT | — | — |
| Shanghai dental labs INC. | China | Maker | Backing and facing for an artificial tooth | — | — |
| 5 Axis Dental Inc. | Canada | Maker | Artificial teeth--coping, crown, inlay, onlay, veneer | — | — |
| OPCOM Inc. | Taiwan | Maker | Duck Plus TEETH, ARTIFICIAL, BACKING AND FACING | — | — |
| Smart Dental Cad Solutions Limited | China | Maker | Ti implant abutment | — | — |
| MINISH DENTAL LAB Co.,Ltd | South Korea | Maker | MINISH Veneer | — | — |
| Novetec Group Limited | Hong Kong SAR China | Maker | Teeth, Fake, Teeth, Artificial, Backing and Facing | — | — |
| Imagine Milling Technologies, LLC | United States | Contract manufacturer | NextDent C&B; NextDent C&B MFH | 4 | 2026 |
| Amann Girrbach AG | Austria | Foreign exporter | — | 3 | 2026 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | orthom | — | — |
| GLO Science, Inc. | United States | Contract manufacturer | Lammina Veneer | — | — |
| Fire Dental Studio, LLC | United States | Repacker / relabeler | FIRE ELK - Teeth, Artificial, Backing and Facing | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 15 Jul 1981 | K811665 | SR-ISOCETTE | J. Aderer, Inc. |
| 30 Dec 1976 | K760909 | THERMOMETER JARS AND CAPS | Plastics/Packaging |
Official records: FDA product classification for ELK · 21 CFR 872.3910.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026