FDA.reportPublic FDA data

Jensen Premium Dental Alloy

Primary DI
00817340020489
Brand
Jensen Premium Dental Alloy
Company
JENSEN INDUSTRIES INC.
Model
JP-5 1ozt
Catalog number
5041A
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
EJSAlloy, Other Noble Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJSAlloy, Other Noble MetalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817340020489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817340020489008173400204898173400204890817340020489

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
00842092166611CekaPreat CorporationEJS2023-12-21
00842092112922CekaPreat CorporationEJS2023-11-02
00841549118289Platinum Foil 1 DWT STERNGOLD DENTAL LLCEJS2023-10-06
D772031325005000POZZI MALIBU SILVER SOLDERAMERICAN TOOTH INDUSTRIESEJS2023-08-30
D772ATI070290010JUSTI PAKTO PURE ALLOY AMERICAN TOOTH INDUSTRIESEJS2023-08-30
D772ATI070290020JUSTI PAKTO PURE ALLOYAMERICAN TOOTH INDUSTRIESEJS2023-08-30
D772ATI290001K0JUSTI PAKTO PURE ALLOY AMERICAN TOOTH INDUSTRIESEJS2023-08-30
D772ATI32500010POZZI MALIBU SILVER SOLDERAMERICAN TOOTH INDUSTRIESEJS2023-08-30
D772ATI32500050POZZI MALIBU SILVER SOLDERAMERICAN TOOTH INDUSTRIESEJS2023-08-30
10843471101343The Orthodontic StoreYoung Innovations, Inc.EJS2022-11-24
10843471101350The Orthodontic StoreYoung Innovations, Inc.EJS2022-11-24
06970469230253Aidite Firing PasteAidite (Qinhuangdao) Technology Co., Ltd.EJS2022-04-07
D818100025ARGEBOND 80ARGEN CORPORATION, THEEJS2022-03-14
D818100270ARGELITE 50ARGEN CORPORATION, THEEJS2022-03-14
D818100273ARGELITE 54+ARGEN CORPORATION, THEEJS2022-03-14
D818100275ARGELITE 54BARGEN CORPORATION, THEEJS2022-03-14
D818100278ARGELITE 55ARGEN CORPORATION, THEEJS2022-03-14
D818100280ARGELITE 58PARGEN CORPORATION, THEEJS2022-03-14
D818100286ARGELITE 60ARGEN CORPORATION, THEEJS2022-03-14
D818100291ARGELITE 61ARGEN CORPORATION, THEEJS2022-03-14
D818100296ARGELITE 75+6ARGEN CORPORATION, THEEJS2022-03-14
D818100305ARGELITE 76SF+ARGEN CORPORATION, THEEJS2022-03-14
D818100323ARGELITE PF+ARGEN CORPORATION, THEEJS2022-03-14
D818100540ARGELITE 80SF+ARGEN CORPORATION, THEEJS2022-03-14
D818101549ARGELITE 52+ARGEN CORPORATION, THEEJS2022-03-14
D818101555ARGELITE 49ARGEN CORPORATION, THEEJS2022-03-14
D818102525ARGISTAR 40ARGEN CORPORATION, THEEJS2022-03-14
D818104455ARGELITE 70+ARGEN CORPORATION, THEEJS2022-03-14
D818104530ARGELITE 61+3ARGEN CORPORATION, THEEJS2022-03-14
D818104642ARGELITE 59ARGEN CORPORATION, THEEJS2022-03-14