Cleared Traditional

K172543 - High-speed Turbine Handpieces for Singl...

K172543 is an FDA 510(k) clearance for High-speed Turbine Handpieces for Singl..., manufactured by Beijing Dongbo Dental Handpiece Co., Ltd.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K172543 · Beijing Dongbo Dental Handpiece Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
322d
Days
Class 1
Risk

K172543 is an FDA 510(k) clearance for the High-speed Turbine Handpieces for Single Use. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Beijing Dongbo Dental Handpiece Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on July 11, 2018 after a review of 322 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Beijing Dongbo Dental Handpiece Co., Ltd. devices

FDA 510(k) Submission Details - K172543

510(k) Number K172543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2017
Decision Date July 11, 2018
Days to Decision 322 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
195d slower than avg
Panel avg: 127d · This submission: 322d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

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

Mid-Link Consulting Co, Ltd.
Diana Hong

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 90
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K172543.
Dental high speed handpiece, Dental low speed handpiece
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K181110 · Kaltenbach & Voigt GmbH · Apr 2019
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K173943 · Microp Technology (Taiwan), Inc. · Jul 2018
Concentrix MX-AC High-Speed Handpiece
K173465 · Dentalez, Inc. · Mar 2018
PERIO-FLOW nozzle
K171174 · E.M.S Electro Medical Systems S.A · Dec 2017
PANA SPRAY Plus
K163483 · Nakanishi, Inc. · Aug 2017