FDA.reportPublic FDA data

Restoration, Base Metal-BaseAlloy: Crown,Bridge, Inlay, Onlay, Splint, RBR

Primary DI
06970617030063
Brand
Restoration, Base Metal-BaseAlloy: Crown,Bridge, Inlay, Onlay, Splint, RBR
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
EJHAlloy, Metal, Base

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJHAlloy, Metal, BaseDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970617030063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970617030063069706170300636970617030063

GMDN Terms#

Term, Definition table
TermDefinition
Dental casting non-noble alloyA material composed primarily of non-noble metals [e.g., includes alloys such as cobalt-chrome (Co-Cr), nickel-chromium, titanium (Ti)] 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
06970617030018Restoration, Noble Metal--Noble Alloy: Crown, Bridge, Inlay, Onlad, SplintNot Applicable2016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03760357974931Prime V Disc 98.5 x16 mmBERNARD CERVOS SOCIETEEJH2026-06-09
03760357974948Prime V Disc 98.5 x18 mmBERNARD CERVOS SOCIETEEJH2026-06-09
03760357974955Prime V Disc 98.5 x20 mmBERNARD CERVOS SOCIETEEJH2026-06-09
EYET96300010SOLIBOND N, Ni.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-05-11
EYET96390120Solibond N Alloy Blank (98,5), 12mm, 1 diskYeti Dentalprodukte GmbHEJH2026-05-11
EYET96900010SOLIBOND C plus, Co.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-05-11
EYET6050060M0Bite regist. Metal foil wax, brown,SampleYeti Dentalprodukte GmbHEJH2026-04-16
EYET9600100A0Solidur CoCr Partial Denture Alloys 100gYeti Dentalprodukte GmbHEJH2026-04-16
EYET9630001M0Sample SOLIBOND N, Ni.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-04-16
EYET9690001M0Sample SOLIBOND C plus, Co.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-04-16
EYET9600001M0Sample SOLIDUR CoCr Alloy 30gYeti Dentalprodukte GmbHEJH2026-04-13
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08050612202110Magnum Saldatura CoMESA DI SALA GIACOMO & C. SNCEJH2020-11-11
08050612202455Magnum HyperoneMESA DI SALA GIACOMO & C. SNCEJH2020-06-18
08050612202462Magnum HyperoneMESA DI SALA GIACOMO & C. SNCEJH2020-06-18
J011102403890remanium®DENTAURUM GmbH & Co.KGEJH2019-11-20
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