Estelite Color
by Tokuyama Dental Corporation
510(k) K110178
Estelite Color is a Class II device made by Tokuyama Dental Corporation, cleared under FDA 510(k) K110178 on 5 Apr 2011, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110178 | Date5 Apr 2011 | StatusActive |
Official records
- FDA 510(k) database K110178
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBF
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K110178
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Estelite Color 10901 | 10901 | 04548190109012 | — | On the market |
| Estelite Color 10911 | 10911 | 04548190109111 | — | On the market |
| Estelite Color 10912 | 10912 | 04548190109128 | — | On the market |
| Estelite Color 10913 | 10913 | 04548190109135 | — | On the market |
| Estelite Color 10914 | 10914 | 04548190109142 | — | On the market |
| Estelite Color 10915 | 10915 | 04548190109159 | — | On the market |
| Estelite Color 10916 | 10916 | 04548190109166 | — | On the market |
| Estelite Color 10917 | 10917 | 04548190109173 | — | On the market |
| Estelite Color 10918 | 10918 | 04548190109180 | — | On the market |
| Estelite Color 10919 | 10919 | 04548190109197 | — | On the market |
| Estelite Color 10920 | 10920 | 04548190109203 | — | On the market |
| Estelite Color 10921 | 10921 | 04548190109210 | — | On the market |
| Estelite Color 10922 | 10922 | 04548190109227 | — | On the market |
| Estelite Color 10923 | 10923 | 04548190109234 | — | On the market |
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