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PrepSure
Directa AB · Model 92403 · UDI-DI 17310230924039
DZN
Prescription
10
510(k) clearances
663
Adverse events
2
Recalls
384
Facilities
Description
Contains DI (one each): 17310230021967 17310230021974 17310230021981
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.