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OVC3 One Visit Crown
RHONDIUM LIMITED · Model OVC3 McDonald Matrix Band - Premolar Accessories Pack · UDI-DI 09421031795580
10
510(k) clearances
663
Adverse events
2
Recalls
384
Facilities
Description
Packages contain x 6 matrix bands for upper molars 16.17 S (small), 16.17 M (medium), 16.17 L (large), 26.27 S (small), 26.27 M (medium), 26.27 L (large), x 6 matrix bands for lower molars 36.37 S (small), 36.37 M (medium), 36.37 L (large), 46.47 S (small), 46.47 M (medium), 46.47 L (large), x 16 stretch wedges
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-12-22 | Ultradent Products, Inc. | Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was received from the supplier with the floss tether hole not completely punched through |
| 2011-12-12 | Ormco/Sybronendo | The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130C. The correct sterilization |
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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.