510(k) K261956 ยท PEM Dental Barriers And Sleeves
Dental Barriers and Sleeves (AB0006)
| Applicant | ANI Co., Ltd., Suwon-Si, Gyeonggi-Do, KR |
| Decision | Substantially Equivalent, Sep 8, 2026 |
| Received | Jun 11, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261956
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.