Cleared Traditional

K152297 - OBS Anchorage Screw (FDA 510(k) Clearance)

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

K152297 · Bomei Co, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
180d
Days
Class 2
Risk

K152297 is an FDA 510(k) clearance for the OBS 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 February 9, 2016 after a review of 180 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. 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 Bomei Co, Ltd. devices

Submission Details

510(k) Number K152297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2015
Decision Date February 09, 2016
Days to Decision 180 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 127d · This submission: 180d
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 Peers - OAT Implant, Endosseous, Orthodontic

All 50
Devices cleared under the same product code (OAT) and FDA review panel - the closest regulatory comparables to K152297.
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