The following data is part of a premarket notification filed by Cosmedent, Inc with the FDA for Renamel Microfill.
| Device ID | K172707 |
| 510k Number | K172707 |
| Device Name: | Renamel Microfill |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Cosmedent, Inc 401 N. Michigan Ave, Suite 2500 Chicago, IL 60611 |
| Contact | Mary Nowak |
| Correspondent | Mary Nowak 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 | 2017-09-08 |
| Decision Date | 2017-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDEL6073LO0 | K172707 | 000 |
| EDEL6073B00 | K172707 | 000 |
| EDEL6073A60 | K172707 | 000 |
| EDEL6073A50 | K172707 | 000 |
| EDEL6073A40 | K172707 | 000 |
| EDEL6073A30 | K172707 | 000 |
| EDEL6073A20 | K172707 | 000 |
| EDEL6073A10 | K172707 | 000 |
| EDEL6073350 | K172707 | 000 |
| EDEL6073250 | K172707 | 000 |
| EDEL6073150 | K172707 | 000 |
| EDEL60730W0 | K172707 | 000 |
| EDEL6071MI0 | K172707 | 000 |
| EDEL6073B10 | K172707 | 000 |
| EDEL6073B20 | K172707 | 000 |
| EDEL6073LI0 | K172707 | 000 |
| EDEL6073DI0 | K172707 | 000 |
| EDEL6073D40 | K172707 | 000 |
| EDEL6073D30 | K172707 | 000 |
| EDEL6073D20 | K172707 | 000 |
| EDEL6073C50 | K172707 | 000 |
| EDEL6073C40 | K172707 | 000 |
| EDEL6073C30 | K172707 | 000 |
| EDEL6073C20 | K172707 | 000 |
| EDEL6073C10 | K172707 | 000 |
| EDEL6073B40 | K172707 | 000 |
| EDEL6073B30 | K172707 | 000 |
| EDEL6071LO0 | K172707 | 000 |
| EDEL6071LI0 | K172707 | 000 |
| EDEL6071A60 | K172707 | 000 |
| EDEL6071A50 | K172707 | 000 |
| EDEL6071A40 | K172707 | 000 |
| EDEL6071A30 | K172707 | 000 |
| EDEL6071A20 | K172707 | 000 |
| EDEL6071A10 | K172707 | 000 |
| EDEL60710W0 | K172707 | 000 |
| EDEL601SB30 | K172707 | 000 |
| EDEL601SB20 | K172707 | 000 |
| EDEL601SB10 | K172707 | 000 |
| EDEL6151BO0 | K172707 | 000 |
| EDEL6071OP0 | K172707 | 000 |
| EDEL6071B00 | K172707 | 000 |
| EDEL6071B10 | K172707 | 000 |
| EDEL6071DI0 | K172707 | 000 |
| EDEL6071D40 | K172707 | 000 |
| EDEL6071D30 | K172707 | 000 |
| EDEL6071D20 | K172707 | 000 |
| EDEL6071C50 | K172707 | 000 |
| EDEL6071C40 | K172707 | 000 |
| EDEL6071C30 | K172707 | 000 |
| EDEL6071C20 | K172707 | 000 |
| EDEL6071C10 | K172707 | 000 |
| EDEL6071B40 | K172707 | 000 |
| EDEL6071B30 | K172707 | 000 |
| EDEL6071B20 | K172707 | 000 |
| EDEL6073OP0 | K172707 | 000 |
| EDEL6073MI0 | K172707 | 000 |
| D779615SB30 | K172707 | 000 |
| D7796151C30 | K172707 | 000 |
| D7796151C20 | K172707 | 000 |
| D7796151C10 | K172707 | 000 |
| D7796151BO0 | K172707 | 000 |
| D7796151B40 | K172707 | 000 |
| D7796151B30 | K172707 | 000 |
| D7796151B20 | K172707 | 000 |
| D7796151B10 | K172707 | 000 |
| D7796151A60 | K172707 | 000 |
| D7796151A50 | K172707 | 000 |
| D7796151A40 | K172707 | 000 |
| D7796151A30 | K172707 | 000 |
| D7796151C40 | K172707 | 000 |
| D7796151C50 | K172707 | 000 |
| D779615SB20 | K172707 | 000 |
| D779615SB10 | K172707 | 000 |
| D779615A350 | K172707 | 000 |
| D779615A250 | K172707 | 000 |
| D779615A150 | K172707 | 000 |
| D7796151MI0 | K172707 | 000 |
| D7796151LO0 | K172707 | 000 |
| D7796151LI0 | K172707 | 000 |
| D7796151D40 | K172707 | 000 |
| D7796151D30 | K172707 | 000 |
| D7796151D20 | K172707 | 000 |
| D7796151CI0 | K172707 | 000 |
| D7796151A20 | K172707 | 000 |
| D7796151A10 | K172707 | 000 |
| EDEL6151B30 | K172707 | 000 |
| EDEL6151B20 | K172707 | 000 |
| EDEL6151B10 | K172707 | 000 |
| EDEL6151A40 | K172707 | 000 |
| EDEL6151A30 | K172707 | 000 |
| EDEL6151A20 | K172707 | 000 |
| EDEL6151A10 | K172707 | 000 |
| EDEL607A350 | K172707 | 000 |
| EDEL607A250 | K172707 | 000 |
| EDEL607A150 | K172707 | 000 |
| EDEL6073S30 | K172707 | 000 |
| EDEL6073S20 | K172707 | 000 |
| EDEL6151C10 | K172707 | 000 |
| EDEL6151C20 | K172707 | 000 |
| D77961510W0 | K172707 | 000 |
| EDEL615SB30 | K172707 | 000 |
| EDEL615SB20 | K172707 | 000 |
| EDEL615SB10 | K172707 | 000 |
| EDEL615A350 | K172707 | 000 |
| EDEL615A250 | K172707 | 000 |
| EDEL6151MI0 | K172707 | 000 |
| EDEL6151LI0 | K172707 | 000 |
| EDEL6151D30 | K172707 | 000 |
| EDEL6151D20 | K172707 | 000 |
| EDEL6151C40 | K172707 | 000 |
| EDEL6151C30 | K172707 | 000 |
| EDEL6073S10 | K172707 | 000 |