FDA.reportPublic FDA data

3M™ Unitek™ Lingual Sheaths

Primary DI
00652221303134
Brand
3M™ Unitek™ Lingual Sheaths
Company
3M UNITEK CORPORATION
Model
080-211P
Catalog number
080-211P
Device description
3M™ Unitek™ Lingual Sheaths, 080-211P, U/L, .036, Hk, 5/Pk
Published
2026-04-25
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
DYOBAND, MATERIAL, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYOBand, Material, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00652221303134PrimaryGS10
80652221303130Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00652221303134006522213031346522213031340652221303134
8065222130313080652221303130

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic metal bandA thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Contacts#

Phone, Email table
PhoneEmail
+1(800)228-3957regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
008256356
Device count
5
Premarket exempt
true
Lot or batch
true
Manufacturing 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
06974720061198Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061204Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061211Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061228Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061235Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061242Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
006522210247323M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-05-07
006522213044453M™ Unitek™3M UNITEK CORPORATIONDYO2026-04-28
006522213044523M™ Unitek™3M UNITEK CORPORATIONDYO2026-04-28
006522213029843M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213029913M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030043M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030113M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030283M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030353M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030423M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030593M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030663M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030733M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030803M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030973M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031033M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031413M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031583M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031723M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031963M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213032023M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213032193M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213032263M™ Unitek™3M UNITEK CORPORATIONDYO2026-04-25
D866HCCP40BPB0Ortho-Tain, IncOrtho-Tain, IncDYO2026-04-01