The following data is part of a premarket notification filed by Schutz-dental Gmbh with the FDA for Tizian Blank, Tizian Zirconium Reinforced Composite Blank, Tizian Color Blank, Tizian Blank Occlusal, Tizian Blank Trans.
| Device ID | K133268 |
| 510k Number | K133268 |
| Device Name: | TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | SCHUTZ-DENTAL GMBH DIESELSTRASSE 5-6 Rosbach, Hessen, DE De 61191 |
| Contact | Michael Wierz |
| Correspondent | Michael Wierz SCHUTZ-DENTAL GMBH DIESELSTRASSE 5-6 Rosbach, Hessen, DE De 61191 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-24 |
| Decision Date | 2015-02-12 |