Cleared Traditional

Motor Handpiece and Control Unit (SDI10)

K251407 · Saeshin Precision Co., Ltd. · Dental
Jan 2026
Decision
269d
Days
Class 1
Risk

About This 510(k) Submission

K251407 is an FDA 510(k) clearance for the Motor Handpiece and Control Unit (SDI10), a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by Saeshin Precision Co., Ltd. (Deagu, KR). The FDA issued a Cleared decision on January 30, 2026, 269 days after receiving the submission on May 6, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K251407 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2025
Decision Date January 30, 2026
Days to Decision 269 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBW — Controller, Foot, Handpiece And Cord
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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