510(k) K202281 ยท KIF Resin, Root Canal Filling
EDS Bioceramic Sealer (Bioseal)
| Applicant | Essential Dental Systems, South Hackensack NJ, US |
| Decision | Substantially Equivalent, Feb 12, 2021 |
| Received | Aug 12, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202281
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.