Cleared Traditional

TRAUS SUS10 (K151171) - 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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

Regulatory Peers - DZI Drill, Bone, Powered

All 13
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K151171.
PIEZOTOME CUBE
K172137 · Satelec - Acteon Group · May 2018
Piezosurgery White
K171326 · Mectron S.P.A. · Apr 2018
PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE
K171958 · Mectron S.P.A. · Jan 2018
SYNTHES 90 DEGREE SCREWDRIVER
K082649 · Synthes (Usa) · Apr 2009
STRYKER ORAL MAX SYSTEM
K954690 · Stryker Corp. · Aug 1996
MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL
K791326 · Sherwood Medical Co. · Oct 1979