Cleared Traditional

Anchor plate (K173623) - FDA 510(k) Clearance

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

K173623 · Biomaterials Korea, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
279d
Days
Class 2
Risk

K173623 is an FDA 510(k) clearance for the Anchor plate. Classified as Implant, Endosseous, Orthodontic (product code OAT), Class II - Special Controls.

Submitted by Biomaterials Korea, Inc. (Hanam-Si, KR). The FDA issued a Cleared decision on August 30, 2018 after a review of 279 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 Biomaterials Korea, Inc. devices

Submission Details

510(k) Number K173623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2017
Decision Date August 30, 2018
Days to Decision 279 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
152d slower than avg
Panel avg: 127d · This submission: 279d
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

Regulatory Insight, Inc.
Jiyea Kim

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 18
Devices cleared under the same product code (OAT) and FDA review panel - the closest regulatory comparables to K173623.
Bio-TackS Orthodontic Mini Implant
K190871 · Biocetec Co., Ltd. · Jan 2020
BIO-RAY A-1 Anchor Screw System
K182929 · Microware Precision Co., Ltd. · Nov 2019
Absoanchor Microimplant
K181142 · Dentos, Inc. · Feb 2019
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
K093299 · Synthes (Usa) · Dec 2010
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
K063473 · Synthes (Usa) · Mar 2007