Cleared Traditional

ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR

K061266 · Ortho Organizers, Inc. · Dental

Jul 2006

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K061266 is an FDA 510(k) clearance for the ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR, a Implant, Endosseous, Orthodontic (Class II — Special Controls, product code OAT), submitted by Ortho Organizers, Inc. (San Diego, US). The FDA issued a Cleared decision on July 31, 2006, 87 days after receiving the submission on May 5, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K061266 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 05, 2006
Decision Date	July 31, 2006
Days to Decision	87 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.