510(k) K243777 · LBH Varnish, Cavity
Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% / Bubble Gum)
| Applicant | Theodent, LLC, New Orleans LA, US |
| Decision | Substantially Equivalent, May 27, 2025 |
| Received | Dec 9, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243777
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.