The following data is part of a premarket notification filed by Biodenta Swiss Ag with the FDA for Ceramics2in1.
| Device ID | K100150 |
| 510k Number | K100150 |
| Device Name: | CERAMICS2IN1 |
| Classification | Powder, Porcelain |
| Applicant | BIODENTA SWISS AG TRAMSTRASSE 16 Berneck, CH 9442 |
| Contact | David Eiler |
| Correspondent | David Eiler BIODENTA SWISS AG TRAMSTRASSE 16 Berneck, CH 9442 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-19 |
| Decision Date | 2010-05-25 |
| Summary: | summary |