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APC™ II Unitek™ Gemini Clear
3M UNITEK CORPORATION · Model 3117-309 · UDI-DI 00652221169167
DYW
Prescription
1
510(k) clearances
45
Adverse events
5
Recalls
27
Facilities
Description
Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) LL3 0T/3A Hk .022 Ea
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-03-25 | Ormco/Sybronendo | Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 081351013, because the ID dot, which designates the bracket as distal/gingival, is m |
| 2011-05-18 | Ormco Corporation | Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error. |
| 2011-05-18 | Ormco Corporation | Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error. |
| 2005-11-03 | Ormco Corporation | Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance. |
| 2005-11-03 | Ormco Corporation | Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.