FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040065072
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1065463
Catalog number
1065463
Device description
MOLAR BAND LR 1ST 41.5 (2)
Published
2020-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ECMBAND, PREFORMED, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECMBand, Preformed, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040065072PrimaryGS10
00304040065075Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404006507210304040065072
00304040065075003040400650753040400650750304040065075

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
2
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040195472Essentials570582857058282026-09-04
10304040195489Essentials570582957058292026-09-04
10304040195038Criterion570581557058152026-07-29
10304040195045Criterion570581657058162026-07-29
10304040195052Criterion570581757058172026-07-29
10304040195069Criterion570581857058182026-07-29
10304040195076Criterion570582057058202026-07-29
10304040195083Criterion570581957058192026-07-29
10304040195090Criterion570582157058212026-07-29
10304040195106Criterion570582257058222026-07-29
00304040194416Henry Schein570572557057252026-07-20
00304040194423Henry Schein570572757057272026-07-20
00304040194430Henry Schein570572857057282026-07-20
00304040194447Henry Schein570572957057292026-07-20
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456206225JMUJMU DENTAL, INCECM2026-06-25
00840456206232JMUJMU DENTAL, INCECM2026-06-25
08033707035015LEONE SPALEONE SPAECM2020-11-10
08033707035022LEONE SPALEONE SPAECM2020-11-10
08033707035039LEONE SPALEONE SPAECM2020-11-10
08033707035046LEONE SPALEONE SPAECM2020-11-10
08033707035053LEONE SPALEONE SPAECM2020-11-10
08033707035060LEONE SPALEONE SPAECM2020-11-10
08033707035077LEONE SPALEONE SPAECM2020-11-10
08033707035084LEONE SPALEONE SPAECM2020-11-10
08033707035091LEONE SPALEONE SPAECM2020-11-10
08033707035107LEONE SPALEONE SPAECM2020-11-10
08033707035114LEONE SPALEONE SPAECM2020-11-10
08033707035121LEONE SPALEONE SPAECM2020-11-10
08033707035138LEONE SPALEONE SPAECM2020-11-10
08033707035145LEONE SPALEONE SPAECM2020-11-10
08033707035152LEONE SPALEONE SPAECM2020-11-10
08033707035169LEONE SPALEONE SPAECM2020-11-10
08033707035176LEONE SPALEONE SPAECM2020-11-10
08033707035183LEONE SPALEONE SPAECM2020-11-10
08033707035190LEONE SPALEONE SPAECM2020-11-10
08033707035206LEONE SPALEONE SPAECM2020-11-10
08033707035213LEONE SPALEONE SPAECM2020-11-10
08033707035220LEONE SPALEONE SPAECM2020-11-10
08033707035237LEONE SPALEONE SPAECM2020-11-10
08033707035244LEONE SPALEONE SPAECM2020-11-10
08033707035251LEONE SPALEONE SPAECM2020-11-10
08033707035268LEONE SPALEONE SPAECM2020-11-10
08033707035275LEONE SPALEONE SPAECM2020-11-10
08033707035282LEONE SPALEONE SPAECM2020-11-10