E-1 Esthetic Composite System
by Tokuyama Dental Corporation
510(k) K072746
E-1 Esthetic Composite System is a Class II device made by Tokuyama Dental Corporation, cleared under FDA 510(k) K072746 on 4 Dec 2007, 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 | NumberK072746 | Date4 Dec 2007 | StatusActive |
Official records
- FDA 510(k) database K072746
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- Withdrawn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 K072746
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 Omega 10701 | 10701 | 04548190107018 | On the market | |
| Estelite Omega 10702 | 10702 | 04548190107025 | On the market | |
| Estelite Omega 10711 | 10711 | 04548190107117 | On the market | |
| Estelite Omega 10712 | 10712 | 04548190107124 | On the market | |
| Estelite Omega 10721 | 10721 | 04548190107216 | On the market | |
| Estelite Omega 10722 | 10722 | 04548190107223 | On the market | |
| Estelite Omega 10723 | 10723 | 04548190107230 | On the market | |
| Estelite Omega 10724 | 10724 | 04548190107247 | On the market | |
| Estelite Omega 10725 | 10725 | 04548190107254 | On the market | |
| Estelite Omega 10726 | 10726 | 04548190107261 | On the market | |
| Estelite Omega 10727 | 10727 | 04548190107278 | On the market | |
| Estelite Omega 10728 | 10728 | 04548190107285 | On the market | |
| Estelite Omega 10729 | 10729 | 04548190107292 | On the market | |
| Estelite Omega 10730 | 10730 | 04548190107308 | On the market | |
| Estelite Omega 10731 | 10731 | 04548190107315 | On the market | |
| Estelite Omega 10741 | 10741 | 04548190107414 | On the market | |
| Estelite Omega 10742 | 10742 | 04548190107421 | On the market | |
| Estelite Omega 10743 | 10743 | 04548190107438 | On the market | |
| Estelite Omega 10744 | 10744 | 04548190107445 | On the market | |
| Estelite Omega 10745 | 10745 | 04548190107452 | On the market | |
| Estelite Omega 10746 | 10746 | 04548190107469 | On the market | |
| Estelite Omega 10747 | 10747 | 04548190107476 | On the market | |
| Estelite Omega 10748 | 10748 | 04548190107483 | On the market | |
| Estelite Omega 10749 | 10749 | 04548190107490 | On the market | |
| Estelite Omega 10750 | 10750 | 04548190107506 | On the market | |
| Estelite Omega 10751 | 10751 | 04548190107513 | On the market |
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