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Stern Weber
CEFLA SOCIETA' COOPERATIVA · Model i-XS4 · UDI-DI 08033837930747
EBW
Prescription
10
510(k) clearances
392
Adverse events
2
Recalls
69
Facilities
Description
The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units. They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear-reducing, or gear increasing speed. They are intended for professional use in dental surgery such as: preventive dentistry, restorative applications, endodontic treatment, prosthetic applications and implantology practices.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-21 | W & H DentalWerk Burmoos GMBH - Site 1 | During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2. In case the error occurs, the foot |
| 2013-10-24 | Nobel Biocare Usa Llc | The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the OseeoCare Pro iPad application software release 1.2.0.7. |
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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.