510(k) K071891 ยท EFB Handpiece, Air-Powered, Dental
STATIS DENTAL HANDPIECES
| Applicant | Scican , Ltd., Toronto, CA |
| Decision | Substantially Equivalent, Sep 13, 2007 |
| Received | Jul 9, 2007 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K071891
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2023 | Coltene Whaledent Inc SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing Open, Classified |
EFB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.