510(k) K061481 ยท DYH Adhesive, Bracket And Tooth Conditioner, Resin
GRENGLOO
| Applicant | Ormco Corp., Newport Beach CA, US |
| Decision | Substantially Equivalent, Jul 6, 2006 |
| Received | May 30, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061481
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2008 | Ormco Corporation Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740 Terminated |
DYH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.