Ultrasonic Endo Activation Device (Model:Actor I Pro)

Scaler, Ultrasonic

ChangZhou BoMedent Medical Technology Co.,Ltd

The following data is part of a premarket notification filed by Changzhou Bomedent Medical Technology Co.,ltd with the FDA for Ultrasonic Endo Activation Device (model:actor I Pro).

Pre-market Notification Details

Device IDK213947
510k NumberK213947
Device Name:Ultrasonic Endo Activation Device (Model:Actor I Pro)
ClassificationScaler, Ultrasonic
Applicant ChangZhou BoMedent Medical Technology Co.,Ltd No.9 Changyang Road,West Taihu Science & Technology Industrial Park, Changzhou,  CN 213100
ContactYang Chunyuan
CorrespondentYang Chunyuan
ChangZhou BoMedent Medical Technology Co.,Ltd No.9 Changyang Road,West Taihu Science & Technology Industrial Park, Changzhou,  CN 213100
Product CodeELC  
CFR Regulation Number872.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-17
Decision Date2022-09-08

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