The following data is part of a premarket notification filed by Doxa Dental Ab with the FDA for Ceramir Restore Quikcap.
| Device ID | K201937 |
| 510k Number | K201937 |
| Device Name: | Ceramir Restore QuikCap |
| Classification | Cement, Dental |
| Applicant | Doxa Dental AB Axel Johanssons Gata 4-6 Uppsala, SE 75450 |
| Contact | Anna-lisa Tiensuu |
| Correspondent | Anna-lisa Tiensuu Doxa Dental AB Axel Johanssons Gata 4-6 Uppsala, SE 75450 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-13 |
| Decision Date | 2020-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350052430311 | K201937 | 000 |