Cleared Traditional

Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece (K212910) - FDA 510(k) Clearance

Class I Dental device.

K212910 · Shenzhen Carejoy Technology Co., Ltd. · Dental device
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Nov 2022
Decision
430d
Days
Class 1
Risk

K212910 is an FDA 510(k) clearance for the Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Shenzhen Carejoy Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 17, 2022 after a review of 430 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 Shenzhen Carejoy Technology Co., Ltd. devices

Submission Details

510(k) Number K212910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2021
Decision Date November 17, 2022
Days to Decision 430 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
303d slower than avg
Panel avg: 127d · This submission: 430d
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

Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Reanny 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 36
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K212910.
Titanium Turbine
K230888 · Nakanishi, Inc. · Jun 2023
TRAUS Air Dental Handpiece
K221741 · Saeshin Precision Co., Ltd. · Feb 2023
Medidenta High Speed Handpieces
K202674 · Pac-Dent, Inc. · Dec 2022
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