510(k) K132109 ยท LBH Varnish, Cavity
ENAMELAST
| Applicant | Ultradent Products Inc. / Oratech, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Nov 1, 2013 |
| Received | Jul 8, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132109
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2018 | Ultradent Products, Inc. Enamelast Cool Mint/OT Varnish 5% NaF Mint
Label Enamelast Unit Dose 200pk Cool Mint:
Enamelast 5% Sodium Fluoride
Unit Dose 200pk Kit - Cool Mint REF/UP 4352
Rx
CONTENTS:
200 x 0.4 ml Unit Dose
Terminated |
LBH | None listed |
| Jul 6, 2018 | 3M Company - Health Care Business 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush.
Product is applied to tooth surfaces Terminated |
LBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.