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.

Virage Ceramic Brackets · Bracket, Ceramic, Orthodontic → Dental

Name: Virage Ceramic Brackets
Brand: Virage Ceramic Brackets

1manufacturer

154catalogue 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 Virage Ceramic Brackets
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)	K922499
Record published	2016-11-24
Record revised	2020-06-19 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number
Distribution end date	2017-02-01

Catalogue Numbers

Catalogue numbers for Virage Ceramic Brackets
Catalogue number	Size	Status
002-5022V		Withdrawn
002-1002V		Withdrawn
002-5017BV		Withdrawn
002-1014BV		Withdrawn
002-2125BV		Withdrawn
002-1006BV		Withdrawn
002-1027V		Withdrawn
002-1027BV		Withdrawn
002-1033V		Withdrawn
002-1028BV		Withdrawn
002-5008BV		Withdrawn
002-2032BV		Withdrawn
002-2038BV		Withdrawn
002-1035V		Withdrawn
002-2036BV		Withdrawn
002-2005BV		Withdrawn
002-5009BV		Withdrawn
002-1036V		Withdrawn
002-5005V		Withdrawn
002-2106BV		Withdrawn
002-5024V		Withdrawn
002-5023V		Withdrawn
002-2006BV		Withdrawn
002-1026V		Withdrawn
002-2205V		Withdrawn
002-1016BV		Withdrawn
002-2026V		Withdrawn
002-2015BV		Withdrawn
002-1005V		Withdrawn
002-2033BV		Withdrawn
002-2112BV		Withdrawn
002-1012BV		Withdrawn
002-5021V		Withdrawn
002-1024V		Withdrawn
002-2009BV		Withdrawn
002-1013V		Withdrawn
002-2225V		Withdrawn
002-1025V		Withdrawn
002-5014BV		Withdrawn
002-2022V		Withdrawn
002-1011V		Withdrawn
002-2102V		Withdrawn
002-2035BV		Withdrawn
002-2014BV		Withdrawn
002-1034BV		Withdrawn
002-1010V		Withdrawn
002-2038V		Withdrawn
002-2014V		Withdrawn
002-1001V		Withdrawn
002-2027V		Withdrawn
002-5011BV		Withdrawn
002-1031BV		Withdrawn
002-2205BV		Withdrawn
002-1015V		Withdrawn
002-2025BV		Withdrawn
002-2206BV		Withdrawn
002-2017V		Withdrawn
002-2110V		Withdrawn
002-2206V		Withdrawn
002-2025V		Withdrawn
002-2130V		Withdrawn
002-2003V		Withdrawn
002-2008BV		Withdrawn
002-1005BV		Withdrawn
002-1007BV		Withdrawn
002-1008V		Withdrawn
002-2122V		Withdrawn
002-2015V		Withdrawn
002-2034V		Withdrawn
002-1004V		Withdrawn
002-5010V		Withdrawn
002-2226V		Withdrawn
002-2016BV		Withdrawn
002-1013BV		Withdrawn
002-2037V		Withdrawn
002-5016V		Withdrawn
002-2013V		Withdrawn
002-5004V		Withdrawn
002-1014V		Withdrawn
002-1021V		Withdrawn
002-2033V		Withdrawn
002-2034BV		Withdrawn
002-2132BV		Withdrawn
002-5006BV		Withdrawn
002-2005V		Withdrawn
002-5001V		Withdrawn
002-2036V		Withdrawn
002-2018V		Withdrawn
002-2105BV		Withdrawn
002-2104V		Withdrawn
002-2017BV		Withdrawn
002-5007V		Withdrawn
002-5012BV		Withdrawn
002-2004V		Withdrawn
002-5013V		Withdrawn
002-2001V		Withdrawn
002-5012V		Withdrawn
002-2029BV		Withdrawn
002-1036BV		Withdrawn
002-1023V		Withdrawn
002-2126BV		Withdrawn
002-1008BV		Withdrawn
002-5005BV		Withdrawn
002-5011V		Withdrawn
002-5002V		Withdrawn
002-1007V		Withdrawn
002-2121V		Withdrawn
002-1015BV		Withdrawn
002-2024V		Withdrawn
002-2002V		Withdrawn
002-1022V		Withdrawn
002-2010V		Withdrawn
002-5018BV		Withdrawn
002-2101V		Withdrawn
002-1016V		Withdrawn
002-2123V		Withdrawn
002-2016V		Withdrawn
002-1025BV		Withdrawn
002-2007V		Withdrawn
002-1032V		Withdrawn
002-5003V		Withdrawn
002-1032BV		Withdrawn
002-2131BV		Withdrawn
002-2028BV		Withdrawn
002-1012V		Withdrawn
002-2030V		Withdrawn
002-2018BV		Withdrawn
002-1035BV		Withdrawn
002-2037BV		Withdrawn
002-2026BV		Withdrawn
002-1003V		Withdrawn
002-1011BV		Withdrawn
002-2124V		Withdrawn
002-2006V		Withdrawn
002-2012BV		Withdrawn
002-2103V		Withdrawn
002-1033BV		Withdrawn
002-2021V		Withdrawn
002-2031BV		Withdrawn
002-1030V		Withdrawn
002-2226BV		Withdrawn
002-1006V		Withdrawn
002-2035V		Withdrawn
002-2111BV		Withdrawn
002-1031V		Withdrawn
002-1034V		Withdrawn
002-1026BV		Withdrawn
002-5006V		Withdrawn
002-1028V		Withdrawn
002-5015BV		Withdrawn
002-2225BV		Withdrawn
002-2011BV		Withdrawn
002-2023V		Withdrawn
002-2013BV		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
RadiancePlus	American Orthodontics	179

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.

Virage Ceramic Brackets