The following data is part of a premarket notification filed by Cosmedent, Inc with the FDA for Renamel Bulkfill.
| Device ID | K211259 |
| 510k Number | K211259 |
| Device Name: | Renamel Bulkfill |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Cosmedent, Inc 401 North Michigan Avenue, Suite 2500 Chicago, IL 60611 |
| Contact | Gary Chuven |
| Correspondent | Gary Chuven Cosmedent, Inc 401 N Michigan Ave, Suite 2500 Chicago, IL 60611 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-26 |
| Decision Date | 2021-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D779600BFF1 | K211259 | 000 |
| EDEL6722A10 | K211259 | 000 |
| EDEL6722A20 | K211259 | 000 |
| EDEL6722A30 | K211259 | 000 |
| EDEL6722B00 | K211259 | 000 |
| EDEL6722B10 | K211259 | 000 |
| EDEL6722C30 | K211259 | 000 |
| EDEL6722D20 | K211259 | 000 |
| D7796722B01 | K211259 | 000 |
| D7796722C31 | K211259 | 000 |
| D7796722D21 | K211259 | 000 |
| D7796722351 | K211259 | 000 |
| D7796722A11 | K211259 | 000 |
| D7796722A21 | K211259 | 000 |
| D7796722A31 | K211259 | 000 |
| D7796722B11 | K211259 | 000 |
| EDEL6722350 | K211259 | 000 |