The following data is part of a premarket notification filed by 3m Company with the FDA for Filtek Supreme Ultra Flowable Restorative.
| Device ID | K100235 |
| 510k Number | K100235 |
| Device Name: | FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | 3M COMPANY 3M CENTER,BLDG. 275-2W-08 St. Paul, MN 55144 -1000 |
| Contact | Scott Erickson |
| Correspondent | Scott Erickson 3M COMPANY 3M CENTER,BLDG. 275-2W-08 St. Paul, MN 55144 -1000 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-26 |
| Decision Date | 2010-05-12 |
| Summary: | summary |