The following data is part of a premarket notification filed by 3m Company with the FDA for Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5% Fluoride Varnish, Model 12247.
| Device ID | K090519 |
| 510k Number | K090519 |
| Device Name: | VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247 |
| Classification | Varnish, Cavity |
| Applicant | 3M COMPANY 3M CENTER, BLDG. 260-2A-17 St Paul, MN 55144 -1000 |
| Contact | Karen O'malley |
| Correspondent | Karen O'malley 3M COMPANY 3M CENTER, BLDG. 260-2A-17 St Paul, MN 55144 -1000 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-02-26 |
| Decision Date | 2009-04-15 |
| Summary: | summary |