What is FDA product code NJM?

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.

RadiancePlus · Bracket, Ceramic, Orthodontic → Dental

Name: RadiancePlus
Brand: RadiancePlus

1manufacturer

179catalogue numbers in this listing

3510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code NJM
Manufacturer	City	Province	Registered as	Device types
Wuxi TP Orthodontics Material Co., Ltd.	Wuxi	Jiangsu	Repacker / relabeller	9

Record

Regulatory record for RadiancePlus
Listed by	American Orthodontics, United States
FDA product code	NJM
Device type	Bracket, Ceramic, Orthodontic
Device class	Class 2
Regulation	21 CFR 872.5470
Establishment	Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K080749
Record published	2016-11-24
Record revised	2025-06-19 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, manufacturing date
Distribution end date	2022-05-04

Catalogue Numbers

Catalogue numbers for RadiancePlus
Catalogue number	Size	Status
002-7143B		In distribution
002-7105		In distribution
002-7204		In distribution
002-7201		In distribution
126-030777		In distribution
002-7232B		In distribution
126-029963		In distribution
002-7103B		In distribution
126-029965		In distribution
002-7115		In distribution
002-7107B		In distribution
002-7237B		In distribution
002-7205		In distribution
002-7214B		In distribution
002-7102		In distribution
002-7101		In distribution
002-7221		In distribution
002-7143		In distribution
002-7104B		In distribution
002-7134		In distribution
126-029960		In distribution
002-7114		In distribution
002-7133		In distribution
126-026640		In distribution
002-7113		In distribution
002-7144		In distribution
002-7119		In distribution
002-7137		In distribution
002-7134B		In distribution
002-7213		In distribution
002-7231B		In distribution
002-7225B		In distribution
002-7212		In distribution
002-7234B		In distribution
002-7228B		In distribution
002-7227B		In distribution
002-7145		In distribution
002-7135		In distribution
002-7136B		In distribution
002-7135B		In distribution
002-7107		In distribution
002-7211		In distribution
002-7137B		In distribution
002-7106		In distribution
002-7105B		In distribution
002-7133B		In distribution
002-7225		In distribution
002-7108B		In distribution
002-7141B		In distribution
002-7148		In distribution
002-7120		In distribution
002-7202		In distribution
002-7138B		In distribution
002-7216		In distribution
126-032253		In distribution
002-7108		In distribution
002-7118B		In distribution
002-7140B		In distribution
002-7150		In distribution
126-032254		In distribution
002-7233		In distribution
002-7112		In distribution
002-7139		In distribution
002-7116B		In distribution
126-029962		In distribution
002-7138		In distribution
002-7226		In distribution
002-7238B		In distribution
002-7222		In distribution
002-7144B		In distribution
002-7103		In distribution
002-7232		In distribution
002-7218B		In distribution
002-7113B		In distribution
002-7226B		In distribution
002-7132		In distribution
002-7206B		In distribution
002-7110B		In distribution
002-7212B		In distribution
002-7236		In distribution
002-7231		In distribution
002-7146B		In distribution
002-7136		In distribution
002-7217B		In distribution
002-7149B		In distribution
002-7211B		In distribution
126-029964		In distribution
002-7206		In distribution
002-7116		In distribution
002-7224		In distribution
002-7148B		In distribution
002-7106B		In distribution
002-7115B		In distribution
002-7210		In distribution
002-7120B		In distribution
002-7147B		In distribution
002-7111B		In distribution
002-7145B		In distribution
002-7208B		In distribution
002-7131		In distribution
002-7207B		In distribution
002-7114B		In distribution
002-7119B		In distribution
002-7203		In distribution
002-7142		In distribution
002-7104		In distribution
002-7118		In distribution
002-7223		In distribution
002-7147		In distribution
002-7117		In distribution
002-7235B		In distribution
002-7230		In distribution
002-7215B		In distribution
002-7117B		In distribution
002-7149		In distribution
002-7150B		In distribution
002-7109		In distribution
002-7205B		In distribution
002-7146		In distribution
126-029959		Withdrawn
002-7557		Withdrawn
002-7434		Withdrawn
002-7418B		Withdrawn
002-7432		Withdrawn
002-7417		Withdrawn
002-7457		Withdrawn
002-7555		Withdrawn
002-7410B		Withdrawn
002-7554		Withdrawn
002-7428B		Withdrawn
002-7403B		Withdrawn
002-7447		Withdrawn
002-7654		Withdrawn
002-7427		Withdrawn
002-7458B		Withdrawn
002-7429B		Withdrawn
002-7553		Withdrawn
002-7402		Withdrawn
002-7556		Withdrawn
002-7653		Withdrawn
002-7573		Withdrawn
002-7433B		Withdrawn
002-7449B		Withdrawn
002-7440B		Withdrawn
002-7559		Withdrawn
002-7459B		Withdrawn
002-7434B		Withdrawn
002-7571		Withdrawn
002-7560		Withdrawn
002-7553B		Withdrawn
002-7551		Withdrawn
002-7411B		Withdrawn
002-7433		Withdrawn
002-7409		Withdrawn
002-7652		Withdrawn
002-7401		Withdrawn
002-7578		Withdrawn
002-7572		Withdrawn
002-7570		Withdrawn
002-7403		Withdrawn
002-7558		Withdrawn
002-7554B		Withdrawn
002-7441B		Withdrawn
002-7439		Withdrawn
002-7448B		Withdrawn
002-7574		Withdrawn
002-7431		Withdrawn
002-7577		Withdrawn
002-7651		Withdrawn
002-7552		Withdrawn
002-7572B		Withdrawn
002-7576		Withdrawn
002-7404B		Withdrawn
002-7573B		Withdrawn
002-7579		Withdrawn
002-7404		Withdrawn
126-029961		Withdrawn
002-7575		Withdrawn
002-7419B		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
QuicKlear®	Forestadent Bernhard Förster GmbH	841
Bracket, Ceramic, Orthodontic	Flexmedics	600
Experience	GC Orthodontics America Inc.	500
TruKlear	Forestadent Bernhard Förster GmbH	401
Chic	GC Orthodontics America Inc.	348
Bracket, Ceramic, Orthodontic	Forestadent Bernhard Förster GmbH	342
IN-Ovation® C	Dentsply Sirona Orthodontics Inc.	327
Intrigue	Lancer Orthodontics, Inc.	253
Empower Clear	American Orthodontics	250
Empower Clear Bracket	American Orthodontics	250
InVu Ceramic Brackets	TP Orthodontics, Inc.	226
InVu Readi-Base Brackets	TP Orthodontics, Inc.	173

Showing 12 of 399. All products under Bracket, Ceramic, Orthodontic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K232011	2023-07-07
K122753	2012-12-14
K080749	2008-08-04

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

RadiancePlus