FDA.reportPublic FDA data

Zirlux

Primary DI
H65890095200
Brand
Zirlux
Company
HENRY SCHEIN, INC.
Model
9009520
Catalog number
9009520
Device description
Zirlux NP 98.5x20mm Disc
Published
2016-09-24
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
EJHALLOY, METAL, BASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJHAlloy, Metal, BaseDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H65890095200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental casting non-noble alloyA material composed primarily of non-noble metals [e.g., includes alloys such as cobalt-chrome (Co-Cr), nickel-chromium, titanium (Ti)] intended for use in the fabrication of a dental cast [i.e., a positive copy of a part of the oral anatomy made in an impression (mould), such as a dental crown] or dental restorations and appliances (e.g., porcelain-fused-to-metal crowns and bridge restorations). It is typically available in the form of small ingots or bars that are melted and poured into an impression. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
Premarket exempt
true
Lot or batch
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
03760357974917Prime V Disc 98.5 x13.5 mmBERNARD CERVOS SOCIETEEJH2026-06-09
03760357974924Prime V Disc 98.5 x12 mmBERNARD CERVOS SOCIETEEJH2026-06-09
03760357974931Prime V Disc 98.5 x16 mmBERNARD CERVOS SOCIETEEJH2026-06-09
03760357974948Prime V Disc 98.5 x18 mmBERNARD CERVOS SOCIETEEJH2026-06-09
03760357974955Prime V Disc 98.5 x20 mmBERNARD CERVOS SOCIETEEJH2026-06-09
EYET96300010SOLIBOND N, Ni.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-05-11
EYET96390120Solibond N Alloy Blank (98,5), 12mm, 1 diskYeti Dentalprodukte GmbHEJH2026-05-11
EYET96900010SOLIBOND C plus, Co.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-05-11
EYET6050060M0Bite regist. Metal foil wax, brown,SampleYeti Dentalprodukte GmbHEJH2026-04-16
EYET9600100A0Solidur CoCr Partial Denture Alloys 100gYeti Dentalprodukte GmbHEJH2026-04-16
EYET9630001M0Sample SOLIBOND N, Ni.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-04-16
EYET9690001M0Sample SOLIBOND C plus, Co.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-04-16
EYET9600001M0Sample SOLIDUR CoCr Alloy 30gYeti Dentalprodukte GmbHEJH2026-04-13
06975902950026CoCr Alloy PowderRiton 3D Technology Co., LtdEJH2023-06-04
EBGO505321Mediloy RPDBEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KGEJH2023-05-12
08050612201229Magnum Vip-AMESA DI SALA GIACOMO & C. SNCEJH2020-11-11
08050612202103Magnum Saldatura BMESA DI SALA GIACOMO & C. SNCEJH2020-11-11
08050612202110Magnum Saldatura CoMESA DI SALA GIACOMO & C. SNCEJH2020-11-11
08050612202455Magnum HyperoneMESA DI SALA GIACOMO & C. SNCEJH2020-06-18
08050612202462Magnum HyperoneMESA DI SALA GIACOMO & C. SNCEJH2020-06-18
J011102403890remanium®DENTAURUM GmbH & Co.KGEJH2019-11-20
07630031703088Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703095Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703101Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703118Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703125Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703132Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703149Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703156Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703163Base metal alloyInstitut Straumann AGEJH2019-08-31