FDA.reportPublic FDA data

RH

Primary DI
00816795020242
Brand
RH
Company
AURIDENT INC
Model
0.7 ozt
Device description
Dental alloy restorations
Published
2017-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00816795020242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816795020242008167950202428167950202420816795020242

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
030580955
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816795025445Delta Zirconia Multilayered Translucent DiscD812A1MUL/T2017-03-23
00816795025421Delta Zirconia High Translucent DiscD812C3T2017-03-22
00816795025643Delta Zirconia High Translucent DiscD818D4T2017-03-23
08816795025445Delta Zirconia Multilayered Translucent DiscD812A1MUL/T2017-03-23
00816795024059Delta ZirconiaD810A0G2016-09-15
00816795024080Delta Zirconia TranslucentD810A1T2016-09-19
00816795024097Delta Zirconia TranslucentD810A2T2016-09-19
00816795024103Delta Zirconia TranslucentD810A3T2016-09-19
00816795024110Delta Zirconia TranslucentD810A3.5T2016-09-19
00816795024127Delta Zirconia TranslucentD810B2T2016-09-19
00816795024134Delta Zirconia TranslucentD810B3T2016-09-19
00816795024141Delta Zirconia TranslucentD810C2T2016-09-19
00816795024158Delta Zirconia TranslucentD810C3T2016-09-19
00816795024165Delta Zirconia TranslucentD810D2T2016-09-19
00816795024172Delta Zirconia D812A0G2016-09-19
00816795024196Delta Zirconia TranslucentD812A0TG2016-09-19
00816795024202Delta Zirconia TranslucentD812A1T2016-09-19
00816795024219Delta Zirconia TranslucentD812A2T2016-09-19
00816795024226Delta Zirconia TranslucentD812A3T2016-09-19
00816795024233Delta Zirconia TranslucentD812A3.5T2016-09-19

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