FDA.reportPublic FDA data

System, Optical Impression, CAD/CAM: Crown, Bridge, Inlay, Onaly

Primary DI
06970617030070
Brand
System, Optical Impression, CAD/CAM: Crown, Bridge, Inlay, Onaly
Company
SHENZHEN MINGHAO DENTURES CO., LTD.
Model
Not Applicable
Published
2016-09-14
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
NSPRestoration, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSPRestoration, PorcelainUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970617030070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970617030070069706170300706970617030070

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

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
06970617030018Restoration, Noble Metal--Noble Alloy: Crown, Bridge, Inlay, Onlad, SplintNot Applicable2016-09-13
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
06977053950047ULTRATHINEERBMF Tech (Zhuhai) Inc.NSP2024-12-08
06977053950054ULTRATHINEERBMF Tech (Zhuhai) Inc.NSP2024-12-08
06977512700008DTS, RESTORATION, PORCELAINDTS Digital Dental LabNSP2024-06-13
06977512700015DTS, RESTORATION, PORCELAINDTS Digital Dental LabNSP2024-06-13
06977512700022DTS, RESTORATION, PORCELAINDTS Digital Dental LabNSP2024-06-13
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSP2023-02-20
08936214223329RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214223367Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214223381RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
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08936214224104Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
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08936214223084Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
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08936214221318Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
08936214221226Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-13
08936214221028RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-12
08936214221066RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-12