The following data is part of a premarket notification filed by Doxa Dental Ab with the FDA for Ceramir Crown & Bridge.
| Device ID | K113040 |
| 510k Number | K113040 |
| Device Name: | CERAMIR CROWN & BRIDGE |
| Classification | Cement, Dental |
| Applicant | DOXA DENTAL AB AXEL JOHANSSONS, GATA 4-6 Uppsala, SE Se-754 51 |
| Contact | Margareth Jorvid |
| Correspondent | Margareth Jorvid DOXA DENTAL AB AXEL JOHANSSONS, GATA 4-6 Uppsala, SE Se-754 51 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-12 |
| Decision Date | 2011-12-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D0026076091 | K113040 | 000 |
| 07350052430199 | K113040 | 000 |
| 07350052430175 | K113040 | 000 |
| 07350052430168 | K113040 | 000 |
| 07350052430151 | K113040 | 000 |
| 17310230400328 | K113040 | 000 |
| 17310230400373 | K113040 | 000 |
| 17310230102789 | K113040 | 000 |
| 17310230102772 | K113040 | 000 |
| 07350052430236 | K113040 | 000 |
| 07350052430243 | K113040 | 000 |
| D0026076080 | K113040 | 000 |
| D0026076070 | K113040 | 000 |
| D0026076040 | K113040 | 000 |
| D0026076011 | K113040 | 000 |
| D0026076000 | K113040 | 000 |
| 07350052430298 | K113040 | 000 |
| 07350052430281 | K113040 | 000 |
| 07350052430250 | K113040 | 000 |
| 17310230400304 | K113040 | 000 |