Prosthetic devices · 21 CFR 872 Subpart D
Preformed Gold Denture Teeth
FDA device type “Teeth, Preformed Gold Denture”.
- Companies listing it
- 66 makers
- Brands and models
- 9
- 510(k) clearances
- 10 in five years
- FDA name
- Teeth, Preformed Gold Denture
510(k) clearances per year, 1976–2026
Companies that list ELN
6 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Fseven Dental Technology Zhuhai Co.,ltd | China | Maker | TEETH,PREFORMED GOLD DENTURE | — | — |
| Cometech VN Company Limited | Vietnam | Maker | COMETECH VN | — | — |
| Beijing Yingguan Dental Science&Technology Co.,Ltd. | China | Maker | Cast frame & partial denture noble metal · Cast full denture noble metal | — | — |
| Smile Dental Laboratory Company Limited | China | Maker | FCG | — | — |
| Shanghai dental labs INC. | China | Maker | Preformed gold denture tooth | — | — |
| Sky HKMC International Limited | Hong Kong SAR China | Maker | Base Metal, Restoration, Noble Metal, Restoration · Porcelain,Restoration,Porcelain-Fused-To-Metal: Restoration, Resin · Restoration,Resin-ACCESSORIES,IMPLANT, DENTAL,ENDOSSEoUS: Dentures.Full:Dentures,Partial: Restoration, | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 1 Jun 1977 | K770872 | IMPRESSION MATERIAL, ALGINATE | Espe GmbH (Us) |
Official records: FDA product classification for ELN · 21 CFR 872.3580.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026