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510(k) Data Aggregation
K Number
K213947Device Name
Ultrasonic Endo Activation Device (Model:Actor I pro)
Manufacturer
ChangZhou BoMedent Medical Technology Co.,Ltd
Date Cleared
2022-09-08
(265 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
ChangZhou BoMedent Medical Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ultrasonic Endo Activation Device (Model:Actor I pro ) is an ultrasonic-handpiece which is intended use for rootcanal cleaning and preparation.
The Ultrasonic Endo Activation Device (Model:Actor I pro ) is intended for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.
Device Description
The subject device Ultrasonic Endo Activation Device (Model: Actor I pro) is an auxiliary device for dentists to perform root canal treatment. It is mainly used to clean the root canal with the help of ultrasonic cavitation, so as to assist dentists to complete root canal treatment.
The subject device Ultrasonic Endo Activation Device (Model: Actor I pro) configuration consist of the following components:
(1) ultrasonic handpiece (2) ultrasonic working tip (3) Wrench (4) silicone case (5) charging base
(6) Power Adapter(7) wireless foot switch (Optional)
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