Cleared Traditional

K080749 - RADIANCE

K080749 is an FDA 510(k) clearance for RADIANCE, manufactured by American Orthodontics. The device is a Class 2 Dental device with product code NJM cleared through the Traditional 510(k) pathway after a 140-day FDA review.

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

K080749 is an FDA 510(k) clearance for the RADIANCE. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on August 4, 2008 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all American Orthodontics devices

FDA 510(k) Submission Details - K080749

510(k) Number K080749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 127d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NJM Device Classification - Class 2, Special Controls

Product Code NJM Bracket, Ceramic, Orthodontic
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NJM Bracket, Ceramic, Orthodontic

All 45
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K080749.
CERAMIC BRACKETS
K110335 · Ortho Organizers, Inc. · May 2011
CLICK-IT
K111234 · Tp Orthodontics, Inc. · May 2011
DAMON 4CLEAR
K081415 · Ormco Corp. · Sep 2008
IN-OVATION C
K060837 · Dentsply International · Apr 2006
NEO-CLIP ORTHODONTIC BRACKET ACCESSORY
K042905 · Dentsply Intl. · Nov 2004
ORTHODONTIC CERAMIC BRACKETS
K042178 · Dentsply Intl. · Aug 2004