FDA.reportPublic FDA data

APC™ PLUS Clarity™ ADVANCED

Primary DI
00652221162847
Brand
APC™ PLUS Clarity™ ADVANCED
Company
3M UNITEK CORPORATION
Model
5006-256
Catalog number
5006-256
Device description
Clarity(TM) ADVANCED Bracket APC(TM) PLUS MBT(TM) LR4 -12T/2A .018 5/Pk
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NJMBracket, ceramic, orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJMBracket, Ceramic, OrthodonticDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00652221162847PrimaryGS10
80652221162843Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00652221162847006522211628476522211628470652221162847
8065222116284380652221162843

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, ceramicA ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)423-45883Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
008256356
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
006522210018183M™ Unitek™ Metal Brackets001--227001--2272026-05-07
006522210247323M™ Unitek™ Lingual Sheaths080--216080--2162026-05-07
006522210366983M™ Unitek™ Orthodontic Bands141--000141--0002026-05-07
006522210388693M™ Unitek™ Orthodontic Bands149--000149--0002026-05-07
006522210444403M™ Unitek™ Orthodontic Bands160--000160--0002026-05-07
006522210472503M™ Unitek™185--120185--1202026-05-07
006522210472743M™ Unitek™185--122185--1222026-05-07
006522210473803M™ Unitek™185--133185--1332026-05-07
006522210670363M™ Unitek™ Intraoral Attachments309--151309--1512026-05-07
006522210670433M™ Unitek™ Intraoral Attachments309--152309--1522026-05-07
006522210670503M™ Unitek™ Intraoral Attachments309--153309--1532026-05-07
006522210670743M™ Unitek™ Intraoral Attachments309--155309--1552026-05-07
006522210671113M™ Unitek™ Intraoral Attachments309--158309--1582026-05-07
006522210671283M™ Unitek™ Intraoral Attachments309--159309--1592026-05-07
006522210671423M™ Unitek™ Intraoral Attachments309--161309--1612026-05-07
006522210671593M™ Unitek™ Intraoral Attachments309--162309--1622026-05-07
006522210671663M™ Unitek™ Intraoral Attachments309--163309--1632026-05-07
006522210713163M™ Unitek™ Intraoral Attachments340--017340--0172026-05-07
006522210713233M™ Unitek™ Intraoral Attachments340--018340--0182026-05-07
006522210713303M™ Unitek™ Intraoral Attachments340--019340--0192026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611202772CERAMIC BRACKET ICERAM MBT 0.022 L5R (45) - 1UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDANJM2026-05-26
07908611211422KIT CERAMIC BRACKET ICERAM-P MBT 0.022 - 1 SET + TUBES + WIRESORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDANJM2026-05-26
00190746198359Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198366Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198373Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198380Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198397Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198403Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198410Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198427Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198434Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198441Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198458Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198465Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198472Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198489Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198496Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198502Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198519Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198526Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198533Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198540Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198557Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198564Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198571Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198588Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198595Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198601Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198618Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198625Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23