The following data is part of a premarket notification filed by Ccri, Inc. with the FDA for Pavati Z40.2 Zirconia.
| Device ID | K160867 |
| 510k Number | K160867 |
| Device Name: | Pavati Z40.2 Zirconia |
| Classification | Powder, Porcelain |
| Applicant | CCRI, INC. 1319 CALLE AVANZADO San Clemente, CA 92673 |
| Contact | Robin Carden |
| Correspondent | Robin Carden CCRI, INC. 1319 CALLE AVANZADO San Clemente, CA 92673 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-30 |
| Decision Date | 2016-09-12 |
| Summary: | summary |