The following data is part of a premarket notification filed by Vita Zahnfabrik H. Rauter Gmbh & Co. with the FDA for Vita Suprinity(r).
| Device ID | K132070 |
| 510k Number | K132070 |
| Device Name: | VITA SUPRINITY(R) |
| Classification | Powder, Porcelain |
| Applicant | VITA ZAHNFABRIK H. RAUTER GMBH & CO. 3150 EAST BIRCH STREET Brea, CA 92821 |
| Contact | Nevine Erian |
| Correspondent | Nevine Erian VITA ZAHNFABRIK H. RAUTER GMBH & CO. 3150 EAST BIRCH STREET Brea, CA 92821 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-03 |
| Decision Date | 2014-01-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J017EC4GK103845650 | K132070 | 000 |
| J017EC4GK103745650 | K132070 | 000 |
| J017EC4GK103645650 | K132070 | 000 |