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510(k) K181129

STRONG Dental Handpieces by Saeshin Precision Co., Ltd. — Product Code EGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2019
Date Received
April 30, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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