510(k) K243254 ยท EBC Sealant, Pit And Fissure, And Conditioner
Parkell Pit and Fissure Sealant
| Applicant | Parkell, Inc., Edgewood NJ, US |
| Decision | Substantially Equivalent, Aug 8, 2025 |
| Received | Oct 15, 2024 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K243254
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.