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iCTmotor
Dentium Co., Ltd · Model WL-1 · UDI-DI 08809460309843
1
510(k) clearances
392
Adverse events
2
Recalls
69
Facilities
Description
As an electric drive motor used in the implant surgery by a dental specialist, the iCTmotor is an instrument tool used in cutting pubic bone, setting an implant or abutment when it combines to a hand-piece in which includes a medical drill, and also has the functions necessary to combine with other devices. The motor was designed as being able to control rotational speed (RPM) and torque, and to select variable options and/or cooling water-supply according to surgery steps. The motor has various ratios in the final value of rotational speed and torque, according to a mechanical reduction gear ratio.
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.