Cleared Traditional

OK Handpiece (K221814) - FDA 510(k) Clearance

Class I Dental device.

K221814 · Jaintek Co.,Ltd · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
23d
Days
Class 1
Risk

K221814 is an FDA 510(k) clearance for the OK Handpiece. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Jaintek Co.,Ltd (Ansan-Si, KR). The FDA issued a Cleared decision on July 15, 2022 after a review of 23 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jaintek Co.,Ltd devices

Submission Details

510(k) Number K221814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2022
Decision Date July 15, 2022
Days to Decision 23 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 127d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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

Third Party Review Group, LLC
Dave Yungvirt

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 K221814.
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
Stainless Turbine
K203791 · Nakanishi, Inc. · Jun 2022
Highspeed Airturbine Handpiece
K202371 · Beijing Dongbo Dental Handpiece Co., Ltd. · Nov 2021
Dental Low-speed Handpieces and Accessories
K202786 · Microp Technology (Taiwan), Inc. · Sep 2021