The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Composite Resin Core Paste Material.
| Device ID | K921174 |
| 510k Number | K921174 |
| Device Name: | COMPOSITE RESIN CORE PASTE MATERIAL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | CENTRIX, INC. 30 STRAN RD. Milford, CT 06460 |
| Contact | John Discko |
| Correspondent | John Discko CENTRIX, INC. 30 STRAN RD. Milford, CT 06460 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-11 |
| Decision Date | 1992-09-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817051021362 | K921174 | 000 |
| 00817051021355 | K921174 | 000 |
| 00817051021348 | K921174 | 000 |
| 00817051020624 | K921174 | 000 |
| 00817051020617 | K921174 | 000 |
| 00817051020600 | K921174 | 000 |
| 00817051020594 | K921174 | 000 |
| 00817051020556 | K921174 | 000 |
| 00817051020532 | K921174 | 000 |