The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Identic And Kromafaze Alginate Dental Impression Materials.
| Device ID | K160441 |
| 510k Number | K160441 |
| Device Name: | Identic And KromaFaze Alginate Dental Impression Materials |
| Classification | Material, Impression |
| Applicant | KERR CORPORATION 1717 W. COLLINS AVE. Orange, CA 92867 |
| Contact | Mohammad Saad Ansari |
| Correspondent | Mohammad Saad Ansari SYBRON DENTAL SPECIALTIES 1717 W. COLLINS AVE. Orange, CA 92867 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-17 |
| Decision Date | 2016-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841396116725 | K160441 | 000 |
| 10841396100939 | K160441 | 000 |
| 10841396100922 | K160441 | 000 |
| 00889989080407 | K160441 | 000 |
| 00889989080391 | K160441 | 000 |
| 00889989080384 | K160441 | 000 |
| 00889989080377 | K160441 | 000 |
| 00841396116650 | K160441 | 000 |
| 00841396116582 | K160441 | 000 |
| 10841396100946 | K160441 | 000 |
| 10841396116534 | K160441 | 000 |
| 10841396116541 | K160441 | 000 |
| 10841396116718 | K160441 | 000 |
| 10841396116701 | K160441 | 000 |
| 10841396116695 | K160441 | 000 |
| 10841396116688 | K160441 | 000 |
| 10841396116671 | K160441 | 000 |
| 10841396116572 | K160441 | 000 |
| 10841396116565 | K160441 | 000 |
| 10841396116558 | K160441 | 000 |
| 00841396112959 | K160441 | 000 |