FDA.reportPublic FDA data

3M™ Unitek™ Uni-Twin™

Primary DI
00652221016157
Brand
3M™ Unitek™ Uni-Twin™
Company
3M UNITEK CORPORATION
Model
020-477
Catalog number
020-477
Device description
Mini Uni-Twin(TM) Bracket UL2 10T/9A .018 5/Pk
Published
2018-10-18
Public version status
New
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
EJFBRACKET, METAL, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00652221016157PrimaryGS10
80652221016153Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00652221016157006522210161576522210161570652221016157
8065222101615380652221016153

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. 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
Premarket exempt
true
Lot or batch
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
07898488904056METAL BRACKET ADVANCED ROTH 0.022 - U1R (11) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904063METAL BRACKET ADVANCED ROTH 0.022 - U2R (12) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904070METAL BRACKET ADVANCED ROTH 0.022 - U3R (13) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904087METAL BRACKET ADVANCED ROTH 0.022 - U45R (14,15) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904094METAL BRACKET ADVANCED ROTH 0.022 - U1L (21) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904100METAL BRACKET ADVANCED ROTH 0.022 - U2L (22) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904117METAL BRACKET ADVANCED ROTH 0.022 - U3L (23) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904124METAL BRACKET ADVANCED ROTH 0.022 - U45L (24,25) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904148METAL BRACKET ADVANCED ROTH 0.022 - L3L (33) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904155METAL BRACKET ADVANCED ROTH 0.022 - L4L (34) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904162METAL BRACKET ADVANCED ROTH 0.022 - L5L (35) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904179METAL BRACKET ADVANCED ROTH 0.022 - L3R (43) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904186METAL BRACKET ADVANCED ROTH 0.022 - L4R (44) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904193METAL BRACKET ADVANCED ROTH 0.022 - L5R (45) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908470707678KIT LAUNCH - U-CLIPORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611211286METAL BRACKET U-CLIP INTERACTIVE MBT 0.022 - 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611211859METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - U1RL - (11/21) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611211866METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - W/HOOK U3L/L3R (23/43) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611211873METAL BRACKET PREMIUM ELITE MBT 0.018 - 1 SET (6X6)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611212689METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611212696METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - 1 SET (6X6)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611213525METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - (12/22/31/32/41/42) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611213570METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - W/HOOK U3R/L3L (13/33) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611213921METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - U3RL/U45RL/L345L/L345R - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611215253METAL BRACKET U-CLIP DUAL PLUS – 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
00190746191602Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191619Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191626Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191633Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191640Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23