The following data is part of a premarket notification filed by Ultradent Products Inc. / Oratech Llc with the FDA for Enamelast.
Device ID | K132109 |
510k Number | K132109 |
Device Name: | ENAMELAST |
Classification | Varnish, Cavity |
Applicant | ULTRADENT PRODUCTS INC. / ORATECH LLC 810 N 2200 W Salt Lake City, UT 84116 |
Contact | Karen Kakunes |
Correspondent | Karen Kakunes ULTRADENT PRODUCTS INC. / ORATECH LLC 810 N 2200 W Salt Lake City, UT 84116 |
Product Code | LBH |
CFR Regulation Number | 872.3260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-08 |
Decision Date | 2013-11-01 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENAMELAST 85781528 4580911 Live/Registered |
Ultradent Products, Inc. 2012-11-16 |