FDA.reportPublic FDA data

Restoration, Noble Metal--Noble Alloy: Crown, Bridge, Inlay, Onlad, Splint

Primary DI
06970617030018
Brand
Restoration, Noble Metal--Noble Alloy: Crown, Bridge, Inlay, Onlad, Splint
Company
SHENZHEN MINGHAO DENTURES CO., LTD.
Model
Not Applicable
Published
2016-09-13
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
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
06970617030018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970617030018069706170300186970617030018

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
Ultraviolet Light

Regulatory Flags#

DUNS number
526027843
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970617030032Restoration, Resin: Crown, Bridge, Temporary Inlay, Onlay, SplintNot Applicable2016-09-13
06970617030049Restoration, Porcelain Fused to Metal-PFM, Crown,Bridge, Inlay, OnlayNot Applicable2016-09-13
06970617030025Restoration, Resin: Nightguard, SplintNot Applicable2016-09-13
06970617030087Dentures, Partial-Partial Denture, RPD Not Applicable2016-09-13
06970617030094Dentures, Full-Full Denture, Complete Denture Not Applicable2016-09-13
06970617030100Prosthesis, Hawley Retainer, Palatal Expander, Spacer, Herbst, Nance HoldingArchNot Applicable2016-09-14
06970617030056Restoration, Porcelain-Porcelain: Crown, Bridge,Inaly, OnlayNot Applicable2016-09-13
06970617030070System, Optical Impression, CAD/CAM: Crown, Bridge, Inlay, OnalyNot Applicable2016-09-14
06970617030063Restoration, Base Metal-BaseAlloy: Crown,Bridge, Inlay, Onlay, Splint, RBRNot Applicable2016-09-13

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
D818100270ARGELITE 50ARGEN 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