FDA.reportPublic FDA data

Jensen XT Zirconia

Primary DI
00817340021219
Brand
Jensen XT Zirconia
Company
JENSEN INDUSTRIES INC.
Model
Jensen XT Zr A3 14mm Frames 2pk
Catalog number
40713
Published
2016-09-23
Public version status
Update
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
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817340021219PrimaryGS10
00817340022353Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817340021219008173400212198173400212190817340021219
00817340022353008173400223538173400223530817340022353

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
060018587
Device count
2
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817340026184MiYO Esthetic SystemMiYO High Performance Glaze Paste 6g00152026-03-27
00817340026177MiYO Esthetic SystemMiYO High Performance Glaze Paste 3g00142026-03-09
00817340026047MiYO Esthetic SystemMiYO 3D Trans Shade 1 Fluor Paste 4g00652026-02-21
00817340026054MiYO Esthetic SystemMiYO 3D Trans Shade 2 Fluor Paste 4g00662026-02-21
00817340026061MiYO Esthetic SystemMiYO 3D Trans Shade 3 Fluor Paste 4g00672026-02-21
00817340026078MiYO Esthetic SystemMiYO 3D Trans Shade 4 Fluor Paste 4g00682026-02-21
00817340026085MiYO Esthetic SystemMiYO 3D Trans Shade 5 Fluor Paste 4g00692026-02-21
00817340026092MiYO Esthetic SystemMiYO 3D Trans Shade 6 Fluor Paste 4g00702026-02-21
00817340026108MiYO Esthetic SystemMiYO 3D Trans Shade 7 Fluor Paste 4g00712026-02-21
00817340026115MiYO Esthetic SystemMiYO 3D Trans Shade 8 Fluor Paste 4g00722026-02-21
00817340026122MiYO Esthetic SystemMiYO 3D Trans Shade 9 Fluor Paste 4g00732026-02-21
00817340026139MiYO Esthetic SystemMiYO 3D Trans Shade 10 Fluor Paste 4g00742026-02-21
00817340026146MiYO Esthetic SystemMiYO 3D Trans Shade 11 Fluor Paste 4g00752026-02-21
00817340026153MiYO Esthetic SystemMiYO 3D Esthetic System Core KitMI9672026-02-21
00817340026160MiYO Esthetic SystemMiYO 3D Esthetic System Essential KitMI9682026-02-21
00817340026016MiYO Esthetic SystemMiYO Hi Fusing Gingival Structure Orchid Paste 4g09602026-02-12
00817340026023MiYO Esthetic SystemMiYO Hi Fusing Gingival Structure Frost Paste 4g09622026-02-12
00817340026030MiYO Esthetic SystemMiYO Hi Fusing Gingival Structure Rouge Paste 4g09612026-02-12
00817340023572Jensen XT ZirconiaJensen XT TRAN Zr Mono A1 14mm Frame 2pk550182020-05-04
00817340023589Jensen XT ZirconiaJensen XT TRAN Zr Mono A2 14mm Frame 2pk550192020-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941382286740Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286757Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286764Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286771Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286788Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286795Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286801Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286818Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286825Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286832Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286849Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286856Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286863Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286870Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286887Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286894Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286900Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286917Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286924Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286931Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286948Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286955Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286962Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286979Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286986Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286993Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382287006Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382287013Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382287020Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382287037Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20