510(k) K052477 ยท DYW Bracket, Plastic, Orthodontic
DAMON 3 MODIFIED
| Applicant | Ormco Corp., Orange CA, US |
| Decision | Substantially Equivalent, Nov 30, 2005 |
| Received | Sep 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052477
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2005 | Ormco Corporation Damon 3 Bracket
Upper Right lateral .022 slot
Part Number 491-4210
Lot Number100512025 and 100512020 Terminated |
DYW | None listed |
| Nov 26, 2005 | Ormco Corporation Damon 3 Bracket
Upper Right lateral .022 slot
Part Number 491-4211
Lot Number 100514071 and 100512012 Terminated |
DYW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.