Cleared Traditional

ACR Screw System

K222245 · Biomaterials Korea, Inc. · Dental

Aug 2023

Decision

391d

Days

Class 2

Risk

About This 510(k) Submission

K222245 is an FDA 510(k) clearance for the ACR Screw System, 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 21, 2023, 391 days after receiving the submission on July 26, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K222245 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 2022
Decision Date	August 21, 2023
Days to Decision	391 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.