FDA.reportPublic FDA data

ARGELITE 50

Primary DI
D818100270
Brand
ARGELITE 50
Company
ARGEN CORPORATION, THE
Model
100270
Catalog number
100270
Device description
Alloy other noble metal
Published
2022-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
D818100270PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+1(858) 455-7900pcascone@argen.com

Regulatory Flags#

DUNS number
103095543
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D818138334ArgenTi 98.5x121383341383342026-05-14
D818138335ArgenTi 98.5x13.51383351383352026-05-14
D818138336ArgenTi 98.5x151383361383362026-05-14
D818138337ArgenTi 98.5x181383371383372026-05-14
D818138338ArgenTi 98.5x81383381383382026-05-14
D818138339ArgenTi 98.5x101383391383392026-05-14
D818138344ArgenCoCr 255 98.5x121383441383442026-05-14
D818136997SLM LaserFlex -45u (5kg)1369971369972026-05-07
D818138148SLM PREMIER -30u (5 kg)1381481381482026-05-07
D818138340ArgenTi 98.5x161383401383402026-05-07
D818138341ArgenTi 98.5x201383411383412026-05-07
D818138342ArgenTi 98.5x251383421383422026-05-07
D818138343ArgenTi 98.5x301383431383432026-05-07
D818138345ArgenCoCr 255 98.5x13.51383451383452026-05-07
D818138346ArgenCoCr 255 98.5x151383461383462026-05-07
D818138347ArgenCoCr 255 98.5x181383471383472026-05-07
D818138348ArgenCoCr 255 98.5x201383481383482026-05-07
D818138357ArgenCoCr 255 98.5x221383571383572026-05-07
D818138358ArgenCoCr 255 98.5x251383581383582026-05-07
D818138934SLM PREMIER POWDER(5 kg)1389341389342026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092172766CekaPreat CorporationEJS2023-12-21
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
00843471101346The Orthodontic StoreYoung Innovations, Inc.EJS2022-11-24
00843471101353The Orthodontic StoreYoung Innovations, Inc.EJS2022-11-24
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
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