Cleared Traditional

Dental Electric Motor (K203706) - FDA 510(k) Clearance

Class I Dental device.

K203706 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2022
Decision
391d
Days
Class 1
Risk

K203706 is an FDA 510(k) clearance for the Dental Electric Motor. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Guilin, CN). The FDA issued a Cleared decision on January 13, 2022 after a review of 391 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 K203706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2020
Decision Date January 13, 2022
Days to Decision 391 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
264d slower than avg
Panel avg: 127d · This submission: 391d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EBW Controller, Foot, Handpiece And Cord
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 Joyantech Consulting Co., Ltd.
Field Fu

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 - EBW Controller, Foot, Handpiece And Cord

All 20
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K203706.
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED
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Dental Electric Motor
K202075 · Foshan Cicada Dental Instrument Co, Ltd. · Mar 2022
ELEC-LED
K201191 · Micro-Nx Co., Ltd. · Feb 2022
Impla-NX (Model: ISE-270M)
K201192 · Micro-Nx Co., Ltd. · May 2021
TRAUS SIP20
K201292 · Saeshin Precision Co., Ltd. · Feb 2021
iCTmotor (WL-1)
K193341 · Dentium Co., Ltd. · Sep 2020