Cleared Traditional

SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM

K093299 · Synthes (Usa) · Dental

Dec 2010

Decision

421d

Days

Class 2

Risk

About This 510(k) Submission

K093299 is an FDA 510(k) clearance for the SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM, a Implant, Endosseous, Orthodontic (Class II — Special Controls, product code OAT), submitted by Synthes (Usa) (19380, US). The FDA issued a Cleared decision on December 16, 2010, 421 days after receiving the submission on October 21, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K093299 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 21, 2009
Decision Date	December 16, 2010
Days to Decision	421 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.