FDA.reportPublic FDA data

3M™ AlastiK™

Primary DI
00652221073969
Brand
3M™ AlastiK™
Company
3M UNITEK CORPORATION
Model
406-044
Catalog number
406-044
Device description
3M™ AlastiK™ EZ3 Holder, 406-044, 10/Pk
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
ECIBAND, ELASTIC, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00652221073969PrimaryGS10
80652221073965Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00652221073969006522210739696522210739690652221073969
8065222107396580652221073965

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic retainerAn orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

Contacts#

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

Regulatory Flags#

DUNS number
008256356
Device count
10
Premarket exempt
true
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
07908470707135ORTHODONTIC ELASTIC INTRAORAL - LATEX HEAVY 1/4 - SILMETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908470707142ORTHODONTIC ELASTIC INTRAORAL - LATEX HEAVY 3/16 - SILMETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908470707159ORTHODONTIC ELASTIC INTRAORAL - LATEX MEDIUM 1/4 - SILMETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908470707166ORTHODONTIC ELASTIC INTRAORAL - LATEX MEDIUM 3/16 - SILMETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611205964ORTHOMETRIC ELASTIC STICK LIGATURE - ORANGEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611207944KIT ELASTOMERIC - STICK LIGATURES - 23 COLORSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611207951KIT ELASTOMERIC - ELASTIC CHAIN 1,5M - MEDIUM - 23 COLORSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611207968KIT ELASTOMERIC - MODULAR LIGATURE 22 TIES - 10 COLORSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611210654ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - CARIBBEAN BLUEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611210715ORTHOMETRIC ELASTIC STICK LIGATURE - CORALORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611210722ORTHOMETRIC ELASTIC STICK LIGATURE - MARSALAORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611210739ORTHOMETRIC ELASTIC STICK LIGATURE - CARIBBEAN BLUEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611210746ORTHOMETRIC ELASTIC STICK LIGATURE - NEON GREENORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611211309KIT ELASTOMERIC - MODULAR LIGATURES 22 TIES - 27 COLORSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611212382ORTHOFLEXY ELASTIC CHAIN 4.5M - LONG (.166") -METALIC BLUEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611217288ORTHOFLEXY ELASTIC CHAIN 4.5M - LONG (.166") - CRYSTAL GREENORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611217295ORTHOFLEXY ELASTIC CHAIN 4.5M - LONG (.166") - CRYSTAL REDORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611217301ORTHOFLEXY ELASTIC CHAIN 4.5M - LONG (.166") - PEARL GREENORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611217318ORTHOFLEXY ELASTIC CHAIN 4.5M - CLOSED (.113") - CRYSTAL GREENORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611217325ORTHOFLEXY ELASTIC CHAIN 4.5M - CLOSED (.113") - PEARL GREENORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611217332ORTHOFLEXY ELASTIC CHAIN 4.5M - CLOSED (.113") - CRYSTAL REDORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611217349ORTHOFLEXY ELASTIC CHAIN 4.5M - SHORT (.136") - CRYSTAL GREENORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611217356ORTHOFLEXY ELASTIC CHAIN 4.5M - SHORT (.136") - CRYSTAL REDORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
07908611217363ORTHOFLEXY ELASTIC CHAIN 4.5M - SHORT (.136") - PEARL GREENORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2026-05-27
D771349300101Dental CityICP, INC.ECI2026-05-27
D771349300201Dental CityICP, INC.ECI2026-05-27
D771349300301Dental CityICP, INC.ECI2026-05-27
D771349300401Dental CityICP, INC.ECI2026-05-27
D771349300501Dental CityICP, INC.ECI2026-05-27
D771349300601Dental CityICP, INC.ECI2026-05-27