The following data is part of a premarket notification filed by Dentsply International, Inc. with the FDA for Sultan Tooth Root Desensitizer.
| Device ID | K072342 |
| 510k Number | K072342 |
| Device Name: | SULTAN TOOTH ROOT DESENSITIZER |
| Classification | Varnish, Cavity |
| Applicant | DENTSPLY INTERNATIONAL, INC. SUSQUEHANNA COMMERCE CTR., 221 W. PHILADELPHIA ST., SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL, INC. SUSQUEHANNA COMMERCE CTR., 221 W. PHILADELPHIA ST., SUITE 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 | 2007-08-21 |
| Decision Date | 2007-10-03 |
| Summary: | summary |