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510(k) K172543

High-speed Turbine Handpieces for Single Use by Beijing Dongbo Dental Handpiece Co., Ltd. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2018
Date Received
August 23, 2017
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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