510(k) K943245 ยท DYW Bracket, Plastic, Orthodontic
SPIRIT MB
| Applicant | Sybron Dental Specialties, Inc., Glendora CA, US |
| Decision | Substantially Equivalent, Aug 23, 1994 |
| Received | Jul 6, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943245
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2014 | Ormco/Sybronendo Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013.
Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an arc Terminated |
DYW | None listed |
| Nov 16, 2011 | Ormco Corporation Spirit MB Brackets, part #494-1210.
The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Brac Terminated |
DYW | None listed |
| Nov 16, 2011 | Ormco Corporation Spirit MB Brackets, part #494-1211.
The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Brac Terminated |
DYW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.