Cleared Traditional

TRAUS Air Dental Handpiece (K221741) - FDA 510(k) Clearance

Class I Dental device.

K221741 · Saeshin Precision Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
252d
Days
Class 1
Risk

K221741 is an FDA 510(k) clearance for the TRAUS Air Dental Handpiece. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on February 22, 2023 after a review of 252 days - an extended review 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: 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 K221741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2022
Decision Date February 22, 2023
Days to Decision 252 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
125d slower than avg
Panel avg: 127d · This submission: 252d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFB Handpiece, Air-powered, Dental
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.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 36
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K221741.
High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors
K220179 · Foshan Coxo Medical Instrument Co., Ltd. · Sep 2023
EVO 700 series high speed handpiece
K232243 · Ttbio Corp. · Aug 2023
Titanium Turbine
K230888 · Nakanishi, Inc. · Jun 2023
Medidenta High Speed Handpieces
K202674 · Pac-Dent, Inc. · Dec 2022
Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
K212910 · Shenzhen Carejoy Technology Co., Ltd. · Nov 2022
Dental Air Polishing Handpiece
K221548 · Guilin Woodpecker Medical Instrument Co., Ltd. · Sep 2022