Cleared Traditional

K220179 - High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors (FDA 510(k) Clearance)

Class I Dental device.

K220179 · Foshan Coxo Medical Instrument Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
609d
Days
Class 1
Risk

K220179 is an FDA 510(k) clearance for the High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces.... Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Foshan Coxo Medical Instrument Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on September 22, 2023 after a review of 609 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Foshan Coxo Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K220179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2022
Decision Date September 22, 2023
Days to Decision 609 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
482d slower than avg
Panel avg: 127d · This submission: 609d
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 Consultant

Beijing Believe-Med Technology Service Co., Ltd.
Ray Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 260
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K220179.
Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)
K251388 · Foshan Topmed Dental Co., Ltd. · Jan 2026
High speed air turbine handpiece
K251389 · Foshan Topmed Dental Co., Ltd. · Jan 2026
Synea Fusion Handpieces (Intensiv & Profin)
K242179 · W&H Dentalwerk B?rmoos GmbH · Feb 2025
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
K240337 · Guangdong Jinme Medical Technology Co., Ltd. · Nov 2024
High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)
K241074 · Foshan Soco Precision Instrument Co., Ltd. · Nov 2024
Air Powered Tooth Polishing System (Perio-Mate)
K241880 · Nakanishi, Inc. · Sep 2024