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510(k) K213947

Ultrasonic Endo Activation Device (Model:Actor I pro) by Changzhou Bomedent Medical Technology Co.,Ltd — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2022
Date Received
December 17, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type

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