Cleared Traditional

K202163 - Mico One Orthodontic Screw (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202163 · Ze Fang Technology Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
795d
Days
Class 2
Risk

K202163 is an FDA 510(k) clearance for the Mico One Orthodontic Screw. Classified as Implant, Endosseous, Orthodontic (product code OAT), Class II - Special Controls.

Submitted by Ze Fang Technology Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on October 7, 2022 after a review of 795 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Ze Fang Technology Co., Ltd. devices

Submission Details

510(k) Number K202163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2020
Decision Date October 07, 2022
Days to Decision 795 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
668d slower than avg
Panel avg: 127d · This submission: 795d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAT Implant, Endosseous, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
Definition It Is Intended To Provide A Fixed Anchorage Point For Attachment Of Orthodontic Appliances To Facilitate The Orthodontic Movement Of Teeth. It Is Used Temporarily And Is Removed After Orthodontic Treatment Has Been Completed.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

ZhengCheng Consulting Limited Company
Anita Chen

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 - OAT Implant, Endosseous, Orthodontic

All 50
Devices cleared under the same product code (OAT) and FDA review panel - the closest regulatory comparables to K202163.
Leone Orthodontic Implant TAD (Temporary Anchorage Device)
K242944 · Leone S.P.A. · Jun 2025
Mini Screws
K231502 · Proimtech Saglik Urunleri Anonim Sirketi · Sep 2024
T-FIT
K231913 · Techwin Co., Ltd. · Feb 2024
ACR Screw System
K222245 · Biomaterials Korea, Inc. · Aug 2023
Ortholock Anchorage Devices
K202691 · Craniofacial Technologies, Inc. · Apr 2022
ATOZ Mini-Screw
K210559 · Mk Meditech, Inc. · Dec 2021