510(k) K153334 ยท LBH Varnish, Cavity
Oral-B 5% Sodium Fluoride Varnish
| Applicant | Young Dental Manufacturing Co. 1, LLC, Earth City MO, US |
| Decision | Substantially Equivalent, May 20, 2016 |
| Received | Nov 19, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153334
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2023 | Young Dental Manufacturing I, LLC BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish Open, Classified |
LBH | None listed |
| Oct 30, 2019 | Young Dental Manufacturing Co, LLC Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity. Open, Classified |
LBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.