Cleared Traditional

K192561 - TRAUS SUS20 (FDA 510(k) Clearance)

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

K192561 · Saeshin Precision Co., Ltd. · Dental device
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Optimized for regulatory review, auditing and printing
Jul 2020
Decision
300d
Days
Class 2
Risk

K192561 is an FDA 510(k) clearance for the TRAUS SUS20. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Saeshin Precision Co., Ltd. (Deagu, KR). The FDA issued a Cleared decision on July 13, 2020 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 K192561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2019
Decision Date July 13, 2020
Days to Decision 300 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
173d slower than avg
Panel avg: 127d · This submission: 300d
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.