Cleared Traditional

K192561 - TRAUS SUS20

K192561 is an FDA 510(k) clearance for TRAUS SUS20, manufactured by Saeshin Precision Co., Ltd.. The device is a Class 2 Dental device with product code DZI cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K192561 · Saeshin Precision Co., Ltd. · Dental device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K192561

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
Combination Product No
PCCP Authorized No
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.

DZI Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DZI Drill, Bone, Powered

All 29
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K192561.
MT-Bone
K242432 · Mectron S.P.A. · Aug 2024
Surgical Drive System (Model: ES70, ES90, E8)
K240340 · Guangdong Jinme Medical Technology Co., Ltd. · Jul 2024
Guided Surgery Kit
K231087 · Implant Direct Sybron Manufacturing, LLC · Aug 2023
Surgical Drills
K200265 · Implant Direct Sybron Manufacturing, LLC · Jun 2020
Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip
K192033 · Bennett Jacoby, Dds, Ms, Inc. · Jun 2020
PIEZOTOME CUBE
K172137 · Satelec - Acteon Group · May 2018