The following data is part of a premarket notification filed by Sunstar Butler with the FDA for Protect Tooth Desensitizer.
| Device ID | K050486 |
| 510k Number | K050486 |
| Device Name: | PROTECT TOOTH DESENSITIZER |
| Classification | Varnish, Cavity |
| Applicant | SUNSTAR BUTLER 70 W. MADISON ST., SUITE 3300 Chicago, IL 60602 |
| Contact | Richard O Wood |
| Correspondent | Richard O Wood SUNSTAR BUTLER 70 W. MADISON ST., SUITE 3300 Chicago, IL 60602 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-25 |
| Decision Date | 2005-06-07 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PROTECT TOOTH DESENSITIZER 78616225 3291682 Dead/Cancelled |
Sunstar Americas, Inc. 2005-04-25 |