Prosthetic devices · 21 CFR 872 Subpart D
Resin Denture Hydrophilic Coating
FDA device type “Coating, Denture Hydrophilic, Resin”.
- Companies listing it
- 33 makers
- Brands and models
- 7
- 510(k) clearances
- 30 in five years
- FDA name
- Coating, Denture Hydrophilic, Resin
510(k) clearances per year, 1976–2026
Companies that list EBE
3 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Zhengzhou Huaer Electro-optics Technology Co., Ltd. | China | Maker | resin material | 1 | 2020 |
| one day dental partner | South Korea | Maker | kage Coating, denture hydrophilic, resin | — | — |
| Evoden Industria Comercio Importacao e Exportacao de Produto | Brazil | Maker | Evoflex · Evolut HIR · Evopack · Evopour · +1 | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 27 Oct 1983 | K832500 | CS-11 | Chema-Scutum, Inc. |
| 17 Mar 1983 | K830491 | JOHNSON & JOHNSON OPAQUE COLOR MODIFI | Johnson & Johnson Professionals, Inc. |
| 17 Jul 1979 | K790339 | CONCEPT II | Richardson Merrel, Inc. |
Official records: FDA product classification for EBE · 21 CFR 872.3300.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026