510(k) K170822 ยท NBL Light-Induced Fluorescence Caries Detector
Electronic Caries Detector
| Applicant | Ortek Therapeutics, Inc., Roslyn Heights NY, US |
| Decision | Substantially Equivalent, Sep 11, 2017 |
| Received | Mar 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170822
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.