The following data is part of a premarket notification filed by Zirkonzahn Gmbh with the FDA for Temp Basic, Temp Premium, Temp Premium Flexible, Multistratum Flexible, Therapon, Try-in, Burnout, Try-in & Burnout.
| Device ID | K180562 |
| 510k Number | K180562 |
| Device Name: | TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | Zirkonzahn Gmbh Gewerbegebiet - Zona Industriale An Der Ahr 7 Gais, IT 39030 |
| Contact | Julian Steger |
| Correspondent | Sandra Leitner Zirkonzahn Gmbh Gewerbegebiet - Zona Industriale An Der Ahr 7 Gais, IT 39030 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-05 |
| Decision Date | 2018-06-28 |
| Summary: | summary |