510(k) K033630 ยท DZE Implant, Endosseous, Root-Form
MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK
| Applicant | Rhein 83 Srl, Hoboken NJ, US |
| Decision | Substantially Equivalent, Apr 21, 2004 |
| Received | Nov 17, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033630
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.