FDA.reportPublic FDA data

3M™ Unitek™

Primary DI
00652221098863
Brand
3M™ Unitek™
Company
3M UNITEK CORPORATION
Model
519-562
Catalog number
519-562
Device description
Unitek(TM) Friction Fit Stops .045 Diameter Ea
Published
2022-12-08
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
DZCWIRE, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00652221098863PrimaryGS10
80652221098869Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00652221098863006522210988636522210988630652221098863
8065222109886980652221098869

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic extraoral headgearA dental device used in conjunction with orthodontic appliances to exert pressure on the teeth or the jaws from outside the mouth. An orthodontic headgear will typically have a strap that wraps around the patient's neck or head and an inner bow portion that is fastened to the orthodontic appliance in the patient's mouth, or utilizes rests on the chin and forehead (reverse pull headgear).

Contacts#

Phone, Email table
PhoneEmail
+1(800)228-39573Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
008256356
Device count
100
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
00810042124882OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCDZC2026-10-27
00190707195014Retainer WireOrtho Organizers, Inc.DZC2026-10-20
05056389639589Pg SupplyPg Supply, Inc.DZC2026-09-28
05056389639596Pg SupplyPg Supply, Inc.DZC2026-09-28
05056389639602Pg SupplyPg Supply, Inc.DZC2026-09-28
05056389639619Pg SupplyPg Supply, Inc.DZC2026-09-28
J011520120000Noninium®DENTAURUM GmbH & Co.KGDZC2026-09-04
00840456209363JMUJMU DENTAL, INCDZC2026-06-24
00840456209370JMUJMU DENTAL, INCDZC2026-06-24
00840456209387JMUJMU DENTAL, INCDZC2026-06-24
00840456209394JMUJMU DENTAL, INCDZC2026-06-24
00840456209400JMUJMU DENTAL, INCDZC2026-06-24
00840456209417JMUJMU DENTAL, INCDZC2026-06-24
00840456209424JMUJMU DENTAL, INCDZC2026-06-24
00840456209431JMUJMU DENTAL, INCDZC2026-06-24
00840456209448JMUJMU DENTAL, INCDZC2026-06-24
00840456209455JMUJMU DENTAL, INCDZC2026-06-24
00840456209462JMUJMU DENTAL, INCDZC2026-06-24
00840456209479JMUJMU DENTAL, INCDZC2026-06-24
00840456209486JMUJMU DENTAL, INCDZC2026-06-24
00840456209493JMUJMU DENTAL, INCDZC2026-06-24
00840456209509JMUJMU DENTAL, INCDZC2026-06-24
00840456209516JMUJMU DENTAL, INCDZC2026-06-24
00840456209523JMUJMU DENTAL, INCDZC2026-06-24
00840456209530JMUJMU DENTAL, INCDZC2026-06-24
00840456209547JMUJMU DENTAL, INCDZC2026-06-24
00840456209554JMUJMU DENTAL, INCDZC2026-06-24
00840456209561JMUJMU DENTAL, INCDZC2026-06-24
00840456209578JMUJMU DENTAL, INCDZC2026-06-24
00840456209585JMUJMU DENTAL, INCDZC2026-06-24