The following data is part of a premarket notification filed by 3m Espe Dental Products with the FDA for Vanish Varnish, 5% Sodium Fluoride White Varnish.
| Device ID | K092141 |
| 510k Number | K092141 |
| Device Name: | VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH |
| Classification | Varnish, Cavity |
| Applicant | 3M ESPE DENTAL PRODUCTS 3M CENTER, BLDG 275-2W-08 St Paul, MN 55144 |
| Contact | Tamara L Stanczak |
| Correspondent | Tamara L Stanczak 3M ESPE DENTAL PRODUCTS 3M CENTER, BLDG 275-2W-08 St Paul, MN 55144 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-07-15 |
| Decision Date | 2010-03-10 |
| Summary: | summary |