FDA.reportPublic FDA data

PFM Crown Ni-Cr (NP)

Primary DI
06975031820054
Brand
PFM Crown Ni-Cr (NP)
Company
Beijing Yingguan Dental Technology Co., Ltd.
Model
/
Published
2022-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NSORestoration, Porcelain-Fused-To-Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSORestoration, Porcelain-Fused-To-MetalUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975031820054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975031820054069750318200546975031820054

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made dental crown, metal/ceramicA device made of a combination of metal and tooth-coloured ceramic, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.

Sterilization Methods#

Method table
Method
"[""Ultraviolet Light"", ""Ozone""]"
Ultraviolet Light;Ozone

Regulatory Flags#

DUNS number
560456141
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975031820016Cast Crown Ni-Cr (NP)/2022-09-30
06975031820023Cast Crown Co Cr (NP)/2022-09-30
06975031820030Cast Crown Pure Tianium/2022-09-30
06975031820047Cast Crown Noble Metal/2022-09-30
06975031820061PFM Crown Co Cr (NP)/2022-09-30
06975031820078PFM Crown Pure Titanium/2022-09-30
06975031820085PFM Crown Noble Metal/2022-09-30
06975031820092Cast Pontic Ni-Cr/2022-09-30
06975031820108Cast Pontic Co Cr/2022-09-30
06975031820115Cast Pontic Pure Titanium/2022-09-30
06975031820122Cast Pontic Noble Metal/2022-09-30
06975031820139PFM Pontic Ni-Cr/2022-09-30
06975031820146PFM Pontic Co Cr/2022-09-30
06975031820153PFM Pontic Pure Titanium/2022-09-30
06975031820160PFM Pontic Noble Metal/2022-09-30
06975031820177Fused Resin Pontic Ni-Cr/2022-09-30
06975031820184Fused Resin Pontic Co Cr/2022-09-30
06975031820191Fused Resin Pontic Pure Titanium/2022-09-30
06975031820207Fused Resin Pontic Noble Metal/2022-09-30
06975031820214Resin Crown/2022-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977512700084DTS, RESTORATION, PORCELAIN-FUSEDDTS Digital Dental LabNSO2024-06-13
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSO2023-02-20
08936214229994Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSO2023-02-20
08936214223343Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224005Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224043Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224081Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224128Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224142Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224166Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214225002Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214223183Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-18
08936214223206RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-18
08936214223220RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-18
08936214223268Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-18
08936214223282Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-18
08936214221288RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-17
08936214223008Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-17
08936214223046RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-17
08936214223060Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-17
08936214223107RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-17
08936214221295RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-17
08936214221202Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-13
08936214221066RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-12
08936214221103Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-12
08936214221141Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-12
08936214221073RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-12
08936214220014RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-03
06975031820061PFM Crown Co Cr (NP)Beijing Yingguan Dental Technology Co., Ltd.NSO2022-09-30