The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Incoris Zi.
| Device ID | K062509 |
| 510k Number | K062509 |
| Device Name: | INCORIS ZI |
| Classification | Powder, Porcelain |
| Applicant | SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim, DE D-64625 |
| Contact | Fritz Kolle |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-08-28 |
| Decision Date | 2006-09-12 |