Cleared Traditional

C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS

K063495 · Biomaterials Korea, Inc. · Dental

Jul 2007

Decision

248d

Days

Class 2

Risk

About This 510(k) Submission

K063495 is an FDA 510(k) clearance for the C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS, a Implant, Endosseous, Orthodontic (Class II — Special Controls, product code OAT), submitted by Biomaterials Korea, Inc. (Littleton, US). The FDA issued a Cleared decision on July 26, 2007, 248 days after receiving the submission on November 20, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K063495 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2006
Decision Date	July 26, 2007
Days to Decision	248 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement

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.