The following data is part of a premarket notification filed by Dentsply International, Inc. with the FDA for Cavity Varnish.
| Device ID | K122331 |
| 510k Number | K122331 |
| Device Name: | CAVITY VARNISH |
| Classification | Varnish, Cavity |
| Applicant | DENTSPLY INTERNATIONAL, INC. 221 W. PHILADELPHIA ST., SE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL, INC. 221 W. PHILADELPHIA ST., SE 60 York, PA 17404 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-02 |
| Decision Date | 2012-10-15 |
| Summary: | summary |