Cleared Traditional

K220831 - Dental Implantation Systems

K220831 is an FDA 510(k) clearance for Dental Implantation Systems, manufactured by Foshan Coxo Medical Instrument Co., Ltd.. The device is a Class 1 Dental device with product code EBW cleared through the Traditional 510(k) pathway after a 189-day FDA review.

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

FDA 510(k) Submission Details - K220831

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.

EBW Device Classification - Class 1, General Controls

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 31
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