The following data is part of a premarket notification filed by 3m Espe Dental Products with the FDA for 3m Filtek Universal Restorative.
| Device ID | K183476 |
| 510k Number | K183476 |
| Device Name: | 3M Filtek Universal Restorative |
| Classification | Material, Tooth Shade, Resin |
| Applicant | 3M ESPE Dental Products 2510 Conway Ave. St. Paul, MN 55144 |
| Contact | Lam Duong |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-12-17 |
| Decision Date | 2019-01-02 |
| Summary: | summary |