The following data is part of a premarket notification filed by Dental Solutions, Llc with the FDA for Dentivera Milling Disc.
| Device ID | K160498 |
| 510k Number | K160498 |
| Device Name: | Dentivera Milling Disc |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | Dental Solutions, LLC 7701 Golden Valley Road P.O.Box 270725 Golden Valley, MN 55427 |
| Contact | Kendra Shoulders |
| Correspondent | Brian Edwards NAMSA 4050 Olson Memorial Highway Golden Valley, MN 55442 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-23 |
| Decision Date | 2016-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842326104426 | K160498 | 000 |
| 00842326104419 | K160498 | 000 |
| 00842326104402 | K160498 | 000 |
| 00842326104396 | K160498 | 000 |