Cleared Traditional

Endo Motor (K203320) - FDA 510(k) Clearance

Class I Dental device.

K203320 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2021
Decision
179d
Days
Class 1
Risk

K203320 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 Guilin Woodpecker Medical Instrument Co., Ltd. (Guilin, CN). The FDA issued a Cleared decision on May 10, 2021 after a review of 179 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 Guilin Woodpecker Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K203320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2020
Decision Date May 10, 2021
Days to Decision 179 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
52d slower than avg
Panel avg: 127d · This submission: 179d
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

Emergo Global Consulting, LLC
Giselle Zhang

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 K203320.
Pro M Class
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TRAUS ENDO
K212043 · Saeshin Precision Co., Ltd. · Jun 2022
Cordless Prophy System, Model: i-Polish
K211531 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dec 2021
Endo Motor
K192649 · Foshan Cicada Dental Instrument Co, Ltd. · Mar 2021
PROXEO Twist Cordless Polishing System PL-40 H
K201703 · W&H Dentalwerk Buermoos GmbH · Feb 2021
E-connect S Endo Motor with built-in Apex Locator
K201993 · Changzhou Sifary Medical Technology Co., Ltd. · Jan 2021