The following data is part of a premarket notification filed by Schutz-dental Gmbh with the FDA for Tizian Ceramic, Flow, Plate, Fix & Zr Blanks.
| Device ID | K071010 |
| 510k Number | K071010 |
| Device Name: | TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS |
| Classification | Powder, Porcelain |
| Applicant | SCHUTZ-DENTAL GMBH DIESELSTRASSE 5-6 Rosbach, Hessen, DE D-61191 |
| Contact | Michael Wierz |
| Correspondent | Michael Wierz SCHUTZ-DENTAL GMBH DIESELSTRASSE 5-6 Rosbach, Hessen, DE D-61191 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-09 |
| Decision Date | 2007-08-24 |
| Summary: | summary |