Cleared Traditional

K123695 - TRAUS SIP10 (FDA 510(k) Clearance)

Class I Dental device.

K123695 · Saeshin Precision Co., Ltd. · Dental device
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Optimized for regulatory review, auditing and printing
Dec 2012
Decision
15d
Days
Class 1
Risk

K123695 is an FDA 510(k) clearance for the TRAUS SIP10. Classified as Handpiece, Water-powered (product code EKY), Class I - General Controls.

Submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on December 18, 2012 after a review of 15 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Saeshin Precision Co., Ltd. devices

Submission Details

510(k) Number K123695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2012
Decision Date December 18, 2012
Days to Decision 15 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 127d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

Product Code EKY Handpiece, Water-powered
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.