FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040037031
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5700208
Catalog number
5700208
Device description
Plastic Wedges
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DZNINSTRUMENTS, DENTAL HAND

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20304040037038PackageGS116In Commercial Distribution
30304040037035PackageGS136In Commercial Distribution
10304040037031PrimaryGS10
00304040037034Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404003703820304040037038
3030404003703530304040037035
1030404003703110304040037031
00304040037034003040400370343040400370340304040037034

GMDN Terms#

Term, Definition table
TermDefinition
Dental wedge, single-useA small, dental device intended to be introduced between two adjacent teeth for slight separation during a dental procedure. It is typically used during the placement of a filling material, or to stabilize and support other devices (e.g., a matrix band and/or rubber dam). It may include a removable shield intended to protect the healthy tooth/teeth from damage by the instruments. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity

Regulatory Flags#

DUNS number
012430880
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
D955BBGA351Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA451Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA551Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA701Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BONDNG1Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
00810226102231AiraAIRA, LLCDZN2026-08-26
00810226102248AiraAIRA, LLCDZN2026-08-26
00198506092688ELMED INCORPORATEDELMED INCORPORATEDDZN2026-07-28
E0HM39MI2071Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungDZN2026-07-24
E0HM39MI2081Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungDZN2026-07-24
00190776403867MillenniumAvalign Technologies, Inc.DZN2026-07-21
10860013564701CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564718CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564725CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564732CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564756CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564763CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564770CurvaGc Orthodontics America Inc.DZN2026-05-28
07898488905190INSTRUMENT FOR ICERAM SLB BRACKETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211187CERAMIC NANO TUBE TWEEZERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211255CURVERD SCISSORS FOR ALIGNERSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
G149TBSB7500TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7510TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7520TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7530TBS BASICSACME ENTERPRISE.DZN2026-05-21
08404535018929Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535018950Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019049Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019070Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019131Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29