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510(k) K212910

Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece by Shenzhen Carejoy Technology Co., Ltd. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2022
Date Received
September 13, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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