FDA.reportPublic FDA data

Option®

Primary DI
D001181300050
Brand
Option®
Company
Dentsply International Inc.
Model
Alloy
Catalog number
18130005
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
D001181300050PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight31.1Gram

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
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D0026243451Enhance® mini Finishing System6243456243452022-04-11
D0026243551Enhance® mini Finishing System6243556243552022-04-11
D0026243651Enhance® mini Finishing System6243656243652022-04-11
D0026243751Enhance® mini Finishing System6243756243752022-10-13
D0026243851Enhance® mini Finishing System6243856243852022-04-11
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
D0013010311Ceramco® 3Powder Opaque Modifier Yellow3010312016-09-21

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