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OrthoMax®
Six Month Smiles · Model 906R · UDI-DI 00817645020160
DYH
Prescription
10
510(k) clearances
37
Adverse events (1 deaths)
1
Recalls
66
Facilities
Description
OrthoMax® - Direct Bond 5g (Non Flouride)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2007-10-31 | Ormco Corporation | Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07. |
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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.