Cleared Traditional

Endo Motor (K222548) - FDA 510(k) Clearance

Class I Dental device.

K222548 · Shenzhen Perfect Medical Instruments Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
246d
Days
Class 1
Risk

K222548 is an FDA 510(k) clearance for the Endo Motor. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Shenzhen Perfect Medical Instruments Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 26, 2023 after a review of 246 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Shenzhen Perfect Medical Instruments Co., Ltd. devices

Submission Details

510(k) Number K222548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2022
Decision Date April 26, 2023
Days to Decision 246 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
119d slower than avg
Panel avg: 127d · This submission: 246d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKX Handpiece, Direct Drive, Ac-powered
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

Shanghai Sungo Management Consulting Company Limited.
Jarvis Wu

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 - EKX Handpiece, Direct Drive, Ac-powered

All 28
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K222548.
Dental Handpiece, Wireless Endodontic Handpiece, endoit
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InnerView LC
K232657 · Perimetrics, Inc. · Sep 2023
Endo Motor
K220829 · Foshan Coxo Medical Instrument Co., Ltd. · May 2023
EQ-M
K210475 · Meta Systems Co., Ltd. · Sep 2022
Pro M Class
K213897 · Saeyang Microtech Co., Ltd. · Sep 2022
TRAUS ENDO
K212043 · Saeshin Precision Co., Ltd. · Jun 2022