The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Re / Stasis (tm) Gingival Retraction Paste.
| Device ID | K111348 |
| 510k Number | K111348 |
| Device Name: | RE / STASIS (TM) GINGIVAL RETRACTION PASTE |
| Classification | Cord, Retraction |
| Applicant | CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
| Contact | John Discko |
| Correspondent | John Discko CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
| Product Code | MVL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-13 |
| Decision Date | 2011-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841396198526 | K111348 | 000 |
| 00841396185311 | K111348 | 000 |
| 00841396184390 | K111348 | 000 |
| 00841396184383 | K111348 | 000 |
| 00841396184376 | K111348 | 000 |