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Gentle Hand-Bur Systems
DENTAL CARE FOR ALL INTERNATIONAL · Model P1 · UDI-DI 00196852155521
10
510(k) clearances
663
Adverse events
2
Recalls
382
Facilities
Description
P1 One unit pack. See P2 for description If you have any complaints with our products please call or email us for immediate resolution: email team@dcfai.org / Call +19562801708 (WhatsApp)
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.