FDA.reportPublic FDA data

Jensen Premium Dental Alloy

Primary DI
00817340020229
Brand
Jensen Premium Dental Alloy
Company
JENSEN INDUSTRIES INC.
Model
JP-II 1ozt
Catalog number
5015A
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EJTAlloy, Gold-Based Noble Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJTAlloy, Gold-Based Noble MetalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817340020229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817340020229008173400202298173400202290817340020229

GMDN Terms#

Term, Definition table
TermDefinition
Dental casting noble alloyA material composed primarily of noble metals [e.g., gold (Au), palladium (Pd), platinum (Pt), or silver (Ag)] 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
060018587
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00817340025996MiYO Esthetic SystemMiYO 850 Spray Glaze 40gMI9692023-07-26
00817340025989MiYO Esthetic SystemMiYO 850 Halo Spring Fluor Paste 4g09832023-07-25
00817340026009MiYO Esthetic SystemMiYO 850 Spray Glaze 100gMI9702023-03-22
00817340025972MiYO Esthetic SystemMiYO Esthetic System Glidewell.io KitMI9862023-02-27
00817340025941MiYO Esthetic SystemMiYO Esthetic System Chairside KitMI9972023-02-10
00817340025958MiYO Esthetic SystemMiYO Trans Night Fluor Paste 4g09582023-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
97640173081831Dentalor 60Cendres+Métaux SAEJT2024-07-01
97640173081848Dentalor 60Cendres+Métaux SAEJT2024-07-01
97640173081855Dentalor 60Cendres+Métaux SAEJT2024-07-01
97640173081862Dentalor 60Cendres+Métaux SAEJT2024-07-01
97640173082036Solaro 4Cendres+Métaux SAEJT2024-07-01
97640173082043Solaro 4Cendres+Métaux SAEJT2024-07-01
97640173082050Solaro 4Cendres+Métaux SAEJT2024-07-01
00841549115684Stern 99STERNGOLD DENTAL LLCEJT2023-03-13
D818100057ARGEDENT 51SFARGEN CORPORATION, THEEJT2022-03-14
D818100061ARGEDENT 52ARGEN CORPORATION, THEEJT2022-03-14
D818100064ARGEDENT 52SFARGEN CORPORATION, THEEJT2022-03-14
D818100072ARGEDENT 74ARGEN CORPORATION, THEEJT2022-03-14
D818100075ARGEDENT 75ARGEN CORPORATION, THEEJT2022-03-14
D818100080ARGEDENT B 78PFARGEN CORPORATION, THEEJT2022-03-14
D818100120ARGENCO 10 GRAINARGEN CORPORATION, THEEJT2022-03-14
D818100131ARGENCO BIO 1ARGEN CORPORATION, THEEJT2022-03-14
D818100136ARGENCO 20ARGEN CORPORATION, THEEJT2022-03-14
D818100160ARGENCO 40ARGEN CORPORATION, THEEJT2022-03-14
D00153130803050Degutan®Dentsply International Inc.EJT2019-03-13
D7075797690Academy GoldIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075797780Aquarius HardIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075797800Aquarius HardIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075797940Academy Gold XHIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075797970Aquarius XHIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075797990Aquarius XHIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075798510HGPKF 1015 YIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075798740BioUniversal PKFIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075798760BioUniversal PKFIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075798840Brite GoldIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075798860Brite GoldIVOCLAR VIVADENT, INC.EJT2018-10-29