Cleared Traditional

K151171 - TRAUS SUS10 (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K151171 · Saeshin Precision Co., Ltd. · Dental device
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Sep 2015
Decision
123d
Days
Class 2
Risk

K151171 is an FDA 510(k) clearance for the TRAUS SUS10. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on September 1, 2015 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - 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

Submission Details

510(k) Number K151171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2015
Decision Date September 01, 2015
Days to Decision 123 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 127d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZI Drill, Bone, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.