The following data is part of a premarket notification filed by Phoenix Dental, Inc. with the FDA for Super Seal Tooth Desensitizer.
| Device ID | K120109 |
| 510k Number | K120109 |
| Device Name: | SUPER SEAL TOOTH DESENSITIZER |
| Classification | Varnish, Cavity |
| Applicant | PHOENIX DENTAL, INC. 3452 WEST THOMPSON RD. Fenton, MI 48430 |
| Contact | Jeffrey S Cox |
| Correspondent | Jeffrey S Cox PHOENIX DENTAL, INC. 3452 WEST THOMPSON RD. Fenton, MI 48430 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-13 |
| Decision Date | 2012-03-07 |
| Summary: | summary |