FDA.reportPublic FDA data

3M™ Unitek™

Primary DI
00652221002365
Brand
3M™ Unitek™
Company
3m do Brasil Ltda.
Model
001-623
Catalog number
001-623
Device description
Unitek(TM) Twin Torque Curved Bracket L4 -17T/0A 3.3 mm .022 5/Pk
Published
2018-09-24
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
00652221002365PrimaryGS10
80652221002361Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00652221002365006522210023656522210023650652221002365
8065222100236180652221002361

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
901611820
Device count
10
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
006522210063563M™ Unitek™017-379017-3792018-09-24
006522210063633M™ Unitek™017-380017-3802018-09-24
006522210020203M™ Unitek™001-309001-3092018-09-24
006522210020373M™ Unitek™001-310001-3102018-09-24
006522210020513M™ Unitek™001-327001-3272018-09-24
006522210020683M™ Unitek™001-329001-3292018-09-24
006522210020823M™ Unitek™001-333001-3332018-09-24
006522210020993M™ Unitek™001-334001-3342018-09-24
006522210021053M™ Unitek™001-337001-3372018-09-24
006522210021433M™ Unitek™001-361001-3612018-09-24
006522210021983M™ Unitek™001-374001-3742018-09-24
006522210022043M™ Unitek™001-375001-3752018-09-24
006522210022113M™ Unitek™001-376001-3762018-09-24
006522210022283M™ Unitek™001-377001-3772018-09-24
006522210022423M™ Unitek™001-379001-3792018-09-24
006522210022593M™ Unitek™001-380001-3802018-09-24
006522210022663M™ Unitek™001-381001-3812018-09-24
006522210022973M™ Unitek™001-523001-5232018-09-24
006522210023273M™ Unitek™001-533001-5332018-09-24
006522210023343M™ Unitek™001-534001-5342018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190707192976Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707192983Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707192990Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193003Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193010Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193027Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193034Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193041Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193058Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193065Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193072Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193089Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193096Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193102Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193119Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193126Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
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00190746175503Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
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