FDA.reportPublic FDA data

Zirlux

Primary DI
D8026427290
Brand
Zirlux
Company
ARDENT, INC.
Model
642729
Catalog number
642729
Published
2016-12-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EIHPOWDER, PORCELAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8026427290PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047019725
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7076356940Universal6356946356942016-12-23
D8025625680Avante6525686525682016-12-22
D8026426990Zirlux6426996426992016-12-23
D8026427000Zirlux6427006427002016-12-23
D8026427010Zirlux6427016427012016-12-23
D8026427020Zirlux6427026427022016-12-23
D8026427030Zirlux6427036427032016-12-23
D8026427040Zirlux6427046427042016-12-23
D8026427050Zirlux6427056427052016-12-23
D8026427060Zirlux6427066427062016-12-23
D8026427070Zirlux6427076427072016-12-23
D8026427080Zirlux6427086427082016-12-23
D8026427090Zirlux6427096427092016-12-23
D8026427100Zirlux6427106427102016-12-23
D8026427110Zirlux6427116427112016-12-23
D8026427120Zirlux6427126427122016-12-23
D8026427130Zirlux6427136427132016-12-23
D8026427140Zirlux6427146427142016-12-23
D8026427150Zirlux6427156427152016-12-23
D8026427160Zirlux6427166427162016-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942629805106Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805113Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805120Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805137Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805144Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805151Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805168Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805175Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805182Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805199Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805205Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805212Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805250Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629808985Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809005Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809012Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809029Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809036Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809043Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809074Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809098Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809104Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809111Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809128Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809135Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629808732Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29
06942629808749Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29
06942629808756Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29
06942629808763Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29
06942629808770Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29