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CeraRoot Implant System
CERAROOT SL. · Model 020.001 · UDI-DI 08435453900638
1
510(k) clearances
656
Adverse events
2
Recalls
382
Facilities
Description
CeraRoot Surgical Case (empty). It's used to store all the necessary instruments to perform the dental CeraRoot implant surgery. It's made of polymer resistant to dental autoclaves.
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.