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 |