The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Phosphoric-acid Etching Gel.
| Device ID | K890140 |
| 510k Number | K890140 |
| Device Name: | PHOSPHORIC-ACID ETCHING GEL |
| 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 | 1989-01-13 |
| Decision Date | 1989-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817051020488 | K890140 | 000 |
| 00817051020471 | K890140 | 000 |
| 00817051020464 | K890140 | 000 |
| 00817051020457 | K890140 | 000 |