The following data is part of a premarket notification filed by Matech, Inc. with the FDA for Kromatica Color Changing Alginate.
| Device ID | K974894 |
| 510k Number | K974894 |
| Device Name: | KROMATICA COLOR CHANGING ALGINATE |
| Classification | Material, Impression |
| Applicant | MATECH, INC. 13010 SAN FERNANDO RD. Sylmar, CA 91342 |
| Contact | Paul L Saxton |
| Correspondent | Paul L Saxton MATECH, INC. 13010 SAN FERNANDO RD. Sylmar, CA 91342 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-31 |
| Decision Date | 1998-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843471100134 | K974894 | 000 |
| 00843471100110 | K974894 | 000 |
| 00842452100712 | K974894 | 000 |
| 00842452100705 | K974894 | 000 |