Cleared Traditional

Dental Implantation Systems, Dental Electrical Motors (K220831) - FDA 510(k) Clearance

Class I Dental device.

K220831 · Foshan Coxo Medical Instrument Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
189d
Days
Class 1
Risk

K220831 is an FDA 510(k) clearance for the Dental Implantation Systems, Dental Electrical Motors. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Foshan Coxo Medical Instrument Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on September 27, 2022 after a review of 189 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 Foshan Coxo Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K220831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2022
Decision Date September 27, 2022
Days to Decision 189 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
62d slower than avg
Panel avg: 127d · This submission: 189d
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

Beijing Believe-Med Technology Service Co., Ltd.
Ray 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 - 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 K220831.
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO
K230895 · Cefla S.C. · Apr 2024
Fiber Optic Brushless Electronic Micromotor, model: iM100
K231864 · Codent Technical Industry Co., Ltd. · Mar 2024
Implanter incl. Accessories
K211358 · Guilin Woodpecker Medical Instrument Co., Ltd. · Nov 2022
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED
K213022 · Cefla S.C. · May 2022
Dental Electric Motor
K202075 · Foshan Cicada Dental Instrument Co, Ltd. · Mar 2022
ELEC-LED
K201191 · Micro-Nx Co., Ltd. · Feb 2022