FDA.reportPublic FDA data

Imagine Zirconia

Primary DI
00817340024630
Brand
Imagine Zirconia
Company
JENSEN INDUSTRIES INC.
Model
Imagine X TRAN Zr B1 98x18 Disc
Catalog number
56039
Published
2021-12-22
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112806000JENSEN ZIRCONIAJensen Industries, Inc.2011-12-01EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817340024630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817340024630008173400246308173400246300817340024630

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
1
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
06942508892586ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06942508892593ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06976691250007ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06976691250014ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501003ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501010ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501027ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501034ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501041ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501058ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501065ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501072ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
07615208543582IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543599IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543674IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543681IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543698IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543704IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543711IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543728IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543735IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543858IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543865IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543872IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543889IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543896IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543902IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543919IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544039IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544046IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07