Cleared Special

K202278 - OBS Anchorage Screw, Biokey Anchorage Screw (FDA 510(k) Clearance)

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K202278 · Bomei Co, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2021
Decision
150d
Days
Class 2
Risk

K202278 is an FDA 510(k) clearance for the OBS Anchorage Screw, Biokey Anchorage Screw. Classified as Implant, Endosseous, Orthodontic (product code OAT), Class II - Special Controls.

Submitted by Bomei Co, Ltd. (Taoyuan City, TW). The FDA issued a Cleared decision on January 8, 2021 after a review of 150 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bomei Co, Ltd. devices

Submission Details

510(k) Number K202278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2020
Decision Date January 08, 2021
Days to Decision 150 days
Submission Type Special
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
23d slower than avg
Panel avg: 127d · This submission: 150d
Pathway characteristics
Modification to existing cleared device.

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

Voler Biotech Consulting CO., Ltd.
Chih-Hao Kao

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 K202278.
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
Mico One Orthodontic Screw
K202163 · Ze Fang Technology Co., Ltd. · Oct 2022
Ortholock Anchorage Devices
K202691 · Craniofacial Technologies, Inc. · Apr 2022