ENAMELAST
Varnish, Cavity
ULTRADENT PRODUCTS INC. / ORATECH LLC
The following data is part of a premarket notification filed by Ultradent Products Inc. / Oratech Llc with the FDA for Enamelast.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810118103711 | K132109 | 000 |
| 00810118103704 | K132109 | 000 |
| 00810118103698 | K132109 | 000 |
| 00810118103681 | K132109 | 000 |
| 00810118103674 | K132109 | 000 |
| 00810118103667 | K132109 | 000 |
Trademark Results [ENAMELAST]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENAMELAST 85781528 4580911 Live/Registered |
Ultradent Products, Inc. 2012-11-16 |
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