Cleared Special

SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS

K111809 · Biomaterials Korea, Inc. · Dental

Sep 2011

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K111809 is an FDA 510(k) clearance for the SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS, a Implant, Endosseous, Orthodontic (Class II — Special Controls, product code OAT), submitted by Biomaterials Korea, Inc. (Greenwood Village, US). The FDA issued a Cleared decision on September 26, 2011, 91 days after receiving the submission on June 27, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K111809 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2011
Decision Date	September 26, 2011
Days to Decision	91 days
Submission Type	Special
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.