Cleared Traditional

Highspeed Airturbine Handpiece (K202371) - FDA 510(k) Clearance

Class I Dental device.

K202371 · Beijing Dongbo Dental Handpiece Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2021
Decision
446d
Days
Class 1
Risk

K202371 is an FDA 510(k) clearance for the Highspeed Airturbine Handpiece. 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 November 8, 2021 after a review of 446 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 Beijing Dongbo Dental Handpiece Co., Ltd. devices

Submission Details

510(k) Number K202371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2020
Decision Date November 08, 2021
Days to Decision 446 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
319d slower than avg
Panel avg: 127d · This submission: 446d
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

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 36
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K202371.
Dental Air Polishing Handpiece
K221548 · Guilin Woodpecker Medical Instrument Co., Ltd. · Sep 2022
OK Handpiece
K221814 · Jaintek Co.,Ltd · Jul 2022
Stainless Turbine
K203791 · Nakanishi, Inc. · Jun 2022
Dental Low-speed Handpieces and Accessories
K202786 · Microp Technology (Taiwan), Inc. · Sep 2021
Disposable High Speed Air Turbine Handpiece
K193264 · Ningbo Hpdove Dental Instruments Co., Ltd. · Aug 2020
High-speed air turbine handpiece / Low-speed air turbine handpiece
K181691 · Foshan Wenjian Medical Instrument Co., Ltd. · May 2020