510(k) K060957 ยท DZE Implant, Endosseous, Root-Form
MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM
| Applicant | Blue Sky Bio, LLC, Grayslake IL, US |
| Decision | Substantially Equivalent, May 5, 2006 |
| Received | Apr 7, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060957
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.