The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Cerec Speedglaze.
| Device ID | K160099 |
| 510k Number | K160099 |
| Device Name: | CEREC SpeedGlaze |
| Classification | Powder, Porcelain |
| Applicant | Sirona Dental Systems GmbH Fabrikstrasse 31 Bensheim, DE 64625 |
| Contact | Thomas Diesch |
| Correspondent | Kofi Aninakwa Sirona Dental Systems, Inc. 30-30 47th Avenue, SUITE 500 Long Island City, NY 11101 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-19 |
| Decision Date | 2016-06-02 |
| Summary: | summary |