Home › RHONDIUM LIMITED › OVC3 One Visit Crown
OVC3 One Visit Crown
RHONDIUM LIMITED · Model OVC3 McDonald Matrix Band - Premolar Accessories Pack · UDI-DI 09421031795573
10
510(k) clearances
663
Adverse events
2
Recalls
383
Facilities
Description
Packages contain x6 matrix bands for upper premolars 14.15 S (small), 14.15 M (medium), 14.15 L (large), 24.25 S (small), 24.25 M (medium), 24.25 L (large), x6 matrix bands for lower premolars 34.35 S (small), 34.35 M (medium), 34.35 L (large), 44.45 S (small), 44.45 M (medium), 44.45 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.