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MAX-BOND

Ortho Pro Dent LLC · Model OP961A-01 · UDI-DI 00810152820865

DYH Prescription
1
510(k) clearances
37
Adverse events (1 deaths)
1
Recalls
66
Facilities

Description

Orthodontic adhesive Primer Activated kit 1 x 4 gm syringe & 1 bottle Primer 3 ml & 1 syringe etchant gel 3 ml

Recalls

DateFirmReason
2007-10-31Ormco CorporationMislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07.

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Data 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.