FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040129876
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1007560
Catalog number
1007560
Device description
Plastic Filling Instrument DE
Published
2020-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EIYINSTRUMENT, FILLING, PLASTIC, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040129876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040129876003040401298763040401298760304040129876

GMDN Terms#

Term, Definition table
TermDefinition
Dental restoration carver, resinA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental composite or acrylic resin restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012430880
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25
10304040194055Essentials570567557056752026-06-25
10304040194062Essentials570567657056762026-06-25
10304040194079Essentials570567757056772026-06-25
10304040194086Essentials570567857056782026-06-25
00304040007426Henry Schein101700410170042016-09-24
00304040007433Henry Schein900417190041712016-09-24
00304040007440Henry Schein101562310156232016-09-24
00304040007457Henry Schein101562410156242016-09-24
00304040007464Henry Schein900419290041922016-09-24
00304040007471Henry Schein900419390041932016-09-24
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB4010TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4020TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4030TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4040TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4050TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4060TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4070TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4080TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4140TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4150TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4200TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4210TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4220TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB8130TBS BASICSACME ENTERPRISE.EIY2026-05-18
G149TBSB8010TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149TBSB8020TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149TBSB8030TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149TBSB8040TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149NPBPT0NPSACME ENTERPRISE.EIY2026-05-01
08800075626134OSUNG MNDOSUNG MND Co., Ltd.EIY2025-11-03
07649988072451OdneFill TipOdne AGEIY2024-02-01
10889950005283HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005290HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005306HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005313HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005320HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005337HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005344HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005351HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005368HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12