The following data is part of a premarket notification filed by Tokuyama Dental Corporation with the FDA for Estelite Bulk Fill Flow.
| Device ID | K161353 |
| 510k Number | K161353 |
| Device Name: | ESTELITE BULK FILL Flow |
| Classification | Material, Tooth Shade, Resin |
| Applicant | TOKUYAMA DENTAL CORPORATION 38-9 TAITOU 1-CHOME, TAITOU-KU Tokyo, JP 110-0016 |
| Contact | Keith A. Barritt |
| Correspondent | Keith A. Barritt FISH & RICHARDSON P.C. 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 | 2016-05-16 |
| Decision Date | 2017-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548190127443 | K161353 | 000 |
| 04548190127160 | K161353 | 000 |
| 04548190127177 | K161353 | 000 |
| 04548190127184 | K161353 | 000 |
| 04548190127191 | K161353 | 000 |
| 04548190127351 | K161353 | 000 |
| 04548190127368 | K161353 | 000 |
| 04548190127375 | K161353 | 000 |
| 04548190127382 | K161353 | 000 |
| 04548190127399 | K161353 | 000 |
| 04548190127153 | K161353 | 000 |