Cleared Traditional

RADIANCE

K080749 · American Orthodontics · Dental
Aug 2008
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K080749 is an FDA 510(k) clearance for the RADIANCE, a Bracket, Ceramic, Orthodontic (Class II — Special Controls, product code NJM), submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on August 4, 2008, 140 days after receiving the submission on March 17, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K080749 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2008
Decision Date August 04, 2008
Days to Decision 140 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code NJM — Bracket, Ceramic, Orthodontic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5470
Definition An Orthodontic Ceramic Bracket Is A Device Composed Of Ceramic, Which Is Intended To Be Bonded To A Tooth, Upon Which An Orthodontic Wire Is Used To Move The Tooth To A New Position.