Home / 510(k) Clearances / K251407

510(k) K251407

Motor Handpiece and Control Unit (SDI10) by Saeshin Precision Co., Ltd. — Product Code EBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2026
Date Received
May 6, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Foot, Handpiece And Cord
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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