FDA.reportPublic FDA data

ARGEDENT 40SF (5 dwt)

Primary DI
D818120173
Brand
ARGEDENT 40SF (5 dwt)
Company
ARGEN CORPORATION, THE
Model
120173
Catalog number
120173
Device description
Gold based 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
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
D818120173PrimaryHIBCC0

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
06979878380030Jiahong dental labShenzhen Jiahong Dental Technology Co.,Ltd.EJT2026-04-03
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
97640173080643Esteticor® PlusCendres+Métaux SAEJT2020-11-12
97640173080803V-Delta SpecialCendres+Métaux SAEJT2020-11-12
97640173080834V-DeltaloyCendres+Métaux SAEJT2020-11-12
97640173080865V-Delta SFCendres+Métaux SAEJT2020-11-12
97640173081084V-Gnathos PlusCendres+Métaux SAEJT2020-11-12
97640173081138Esteticor® Implant 58Cendres+Métaux SAEJT2020-11-12
97640173081565Esteticor® Accurate 40Cendres+Métaux SAEJT2020-11-12
97640173081787Pontor MPFCendres+Métaux SAEJT2020-11-12
97640173081930Solaro 3Cendres+Métaux SAEJT2020-11-12
97640173082029Aurofluid 2 PFCendres+Métaux SAEJT2020-11-12
97640173082265S.G 750Cendres+Métaux SAEJT2020-11-12
97640173082272S.W 1100Cendres+Métaux SAEJT2020-11-12
97640173082289S.G 1080Cendres+Métaux SAEJT2020-11-12
97640173082302S.W 1125Cendres+Métaux SAEJT2020-11-12
97640173082319S.G 1030Cendres+Métaux SAEJT2020-11-12
97640173082326S.G 1120Cendres+Métaux SAEJT2020-11-12
D00153130803050Degutan®Dentsply International Inc.EJT2019-03-13
D707NA11905040Y 2 SOLDERIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075797690Academy GoldIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075797780Aquarius HardIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075797800Aquarius HardIVOCLAR VIVADENT, INC.EJT2018-10-29