The following data is part of a premarket notification filed by 3m Espe Dental Products with the FDA for Filtek Bulk Fill Flowable Restorative.
| Device ID | K120453 |
| 510k Number | K120453 |
| Device Name: | FILTEK BULK FILL FLOWABLE RESTORATIVE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | 3M ESPE DENTAL PRODUCTS 3M CENTER; BLDG 260-2A-11 St. Paul, MN 55144 -1000 |
| Contact | Scott Erickson |
| Correspondent | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-02-14 |
| Decision Date | 2012-03-19 |
| Summary: | summary |