The following data is part of a premarket notification filed by Tokuyama Dental Corporation with the FDA for E-1 Esthetic Composite System.
| Device ID | K072746 |
| 510k Number | K072746 |
| Device Name: | E-1 ESTHETIC COMPOSITE SYSTEM |
| Classification | Material, Tooth Shade, Resin |
| Applicant | TOKUYAMA DENTAL CORPORATION 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
| Contact | Keith A Barritt |
| Correspondent | Keith A Barritt TOKUYAMA DENTAL CORPORATION 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-27 |
| Decision Date | 2007-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548190107513 | K072746 | 000 |
| 04548190107285 | K072746 | 000 |
| 04548190107278 | K072746 | 000 |
| 04548190107261 | K072746 | 000 |
| 04548190107254 | K072746 | 000 |
| 04548190107247 | K072746 | 000 |
| 04548190107230 | K072746 | 000 |
| 04548190107223 | K072746 | 000 |
| 04548190107216 | K072746 | 000 |
| 04548190107124 | K072746 | 000 |
| 04548190107117 | K072746 | 000 |
| 04548190107025 | K072746 | 000 |
| 04548190107292 | K072746 | 000 |
| 04548190107308 | K072746 | 000 |
| 04548190107506 | K072746 | 000 |
| 04548190107490 | K072746 | 000 |
| 04548190107483 | K072746 | 000 |
| 04548190107476 | K072746 | 000 |
| 04548190107469 | K072746 | 000 |
| 04548190107452 | K072746 | 000 |
| 04548190107445 | K072746 | 000 |
| 04548190107438 | K072746 | 000 |
| 04548190107421 | K072746 | 000 |
| 04548190107414 | K072746 | 000 |
| 04548190107315 | K072746 | 000 |
| 04548190107018 | K072746 | 000 |