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510(k) K221741

TRAUS Air Dental Handpiece by Saeshin Precision Co., Ltd. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2023
Date Received
June 15, 2022
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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