Cleared Traditional

Anchor plate

K173623 · Biomaterials Korea, Inc. · Dental

Aug 2018

Decision

279d

Days

Class 2

Risk

About This 510(k) Submission

K173623 is an FDA 510(k) clearance for the Anchor plate, a Implant, Endosseous, Orthodontic (Class II — Special Controls, product code OAT), submitted by Biomaterials Korea, Inc. (Hanam-Si, KR). The FDA issued a Cleared decision on August 30, 2018, 279 days after receiving the submission on November 24, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K173623 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	OAT — Implant, Endosseous, Orthodontic
Device Class	Class II — 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.