Cleared Traditional

K251407 - Motor Handpiece and Control Unit (SDI10)

K251407 is an FDA 510(k) clearance for Motor Handpiece and Control Unit (SDI10), manufactured by Saeshin Precision Co., Ltd.. The device is a Class 1 Dental device with product code EBW cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K251407 · Saeshin Precision Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
269d
Days
Class 1
Risk

K251407 is an FDA 510(k) clearance for the Motor Handpiece and Control Unit (SDI10). Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Saeshin Precision Co., Ltd. (Deagu, KR). The FDA issued a Cleared decision on January 30, 2026 after a review of 269 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Saeshin Precision Co., Ltd. devices

FDA 510(k) Submission Details - K251407

510(k) Number K251407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 127d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

EBW Device Classification - Class 1, General Controls

Product Code EBW Controller, Foot, Handpiece And Cord
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

E & M
Sanghwa Myung

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBW Controller, Foot, Handpiece And Cord

All 31
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K251407.
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