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510(k) Data Aggregation
K Number
K242646Device Name
Dental Implant Unit
Manufacturer
Guilin AestheDent Medical Instruments Co., Ltd
Date Cleared
2025-04-11
(220 days)
Product Code
EBW, DAT
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Guilin AestheDent Medical Instruments Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.
Device Description
The Dental Implant Unit is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. The device is composed of main unit, motor with tube, handpiece, foot pedal and holder. Eight different programs can be selected by the user. Switching between these programs is performed by foot control or via touch display. The programs include Positioning, Hole-drilling, Hole-Broadening, Tapping, Implanting, Lock the Abutment Screw, User Defined Mode and Cleaning. The control unit is intended to be used with the motor.
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