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
07898488900621KIT THERMO 35° WIRES - ROUNDS + RECTANGULARS - 100 TENSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611211231STRAIGHT WIRE SS COLBOLOY 0.016X0.022 - RECTANGULAR - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611216366NEW EUROPA I - SS ROUND OVOID WIRE 0.016 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611216373NEW EUROPA I - SS ROUND OVOID WIRE 0.018 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611216380NEW EUROPA I - SS ROUND OVOID WIRE 0.020 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611216397NEW EUROPA I - SS OVOID SQUARE WIRE 0.016X0.016 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611216403NEW EUROPA I - SS OVOID RECTANGULAR WIRE 0.016X0.022 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611216410NEW EUROPA I - SS OVOID RECTANGULAR WIRE 0.017X0.025 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611216427NEW EUROPA I - SS OVOID RECTANGULAR WIRE 0.018X0.025 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611216434NEW EUROPA I - SS OVOID RECTANGULAR WIRE 0.019X0.025 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611216441NEW EUROPA I - SS OVOID RECTANGULAR WIRE 0.021X0.025 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611211736LINGUAL RETAINER STRAIGHT WIRES - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-01-12
07908611212641LINGUAL RETAINER CHAIN - SOFT - 1 METERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-01-12
07908611213853LINGUAL RETAINER CHAIN - HARD - 1 METERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-01-12
07908611210333ICERAM-P MBT 0.022 KIT + 1 PAIR OF ESTHETIC ARCHWIRES + 1 PEARL BLUE MODULARORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-07
07908611211163PREMIUM ELITE KIT ROTH 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-07
07908611211170PREMIUM ELITE KIT MBT 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULARORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-07
07908611210319KIT ICERAM-P ROTH 0.022 + 1 PAIR OF ESTHETIC ARCHWIRE + 1 MODULAR PEARL BLUEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-03
07908470704738KIT ADVANCED METAL BRACKETS ROTH 0.022 10 SETS + ARCHES + ELASTICORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07908470704776KIT ADVANCED METAL BRACKETS MBT 0.022 10 SETS + ARCHES + ELASTICSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07908470704912KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + ELASTICSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07908611204264KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + 4 TUBESORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07908611204271KIT ADVANCED METAL BRACKETS MBT 0.022 01 SET + ARCHES + 4 TUBESORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07899439270497ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07899439270503ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07899439270510ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07899439272583ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07899439292949ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07908611210029"PROMO KIT ADVANCED ROTH 0.022"""ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2024-04-16
07908611210036"PROMO KIT ADVANCED ROTH 0.022"""ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2024-04-16