FDA.reportPublic FDA data

Austenal®

Primary DI
D001N0852000
Brand
Austenal®
Company
Dentsply International Inc.
Model
0.800 White Gold Solder 3 Dwt
Catalog number
N085200
Published
2017-01-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D001N0852000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental soldering alloyA mixture of metals in the form of a thin rod used to solder cast dental restorations. It is a fusible alloy used to join less fusible materials (e.g., other metals, metal wires) through the application of high-temperature heat to the metal components to be joined; the soldering metal melts around the joint to create the fusion. The soldering process operates at lower termperatures than brazing. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight4.65Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)243-1942Prosthetics-Regulatory@dentsplysirona.com

Regulatory Flags#

DUNS number
606173334
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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D0026243551Enhance® mini Finishing System6243556243552022-04-11
D0026243651Enhance® mini Finishing System6243656243652022-04-11
D0026243751Enhance® mini Finishing System6243756243752022-10-13
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D002624550001Polytrays62455000624550002022-07-07
D002624550011Polytrays62455001624550012022-07-07
D002624550021Polytrays62455002624550022022-07-07
D002624551001Polytrays62455100624551002022-07-07
D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
D002624551031Polytrays62455103624551032022-07-07
D002624551051Polytrays62455105624551052022-07-07
D0026076071Calibra® Bio Bioceramic Luting Cement6076076076072022-04-20
D0026590301Palodent® Sectional Matrix System6590306590302019-04-02
D0026590701Palodent® Sectional Matrix System6590706590702019-04-02
D0026631001AutoMate®6631006631002019-04-02
D0013010121Ceramco® 3Powder Opaque i2/i43010122016-09-21
D0013010211Ceramco® 3Powder Opaque D23010212016-09-21
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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