510(k) K962543 ยท EFB Handpiece, Air-Powered, Dental
ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU
| Applicant | Nsk Nakanishi, Inc., Tochigi-Ken, JP |
| Decision | Substantially Equivalent, Sep 11, 1996 |
| Received | Jun 28, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962543
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2016 | Nakanishi Inc. Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico)
The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the Terminated |
EFB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.