The following data is part of a premarket notification filed by 3m Company with the FDA for Filtek One Bulk Fill Restorative.
| Device ID | K163207 |
| 510k Number | K163207 |
| Device Name: | Filtek One Bulk Fill Restorative |
| Classification | Material, Tooth Shade, Resin |
| Applicant | 3M Company 2510 Conway Ave. St. Paul, MN 55144 |
| Contact | Scott Erickson |
| 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 | 2016-11-15 |
| Decision Date | 2016-11-28 |
| Summary: | summary |