FDA.reportPublic FDA data

FMC Inlay

Primary DI
06975031820375
Brand
FMC Inlay
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
NSPRestoration, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSPRestoration, PorcelainUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975031820375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975031820375069750318203756975031820375

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

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
06975031820054PFM Crown Ni-Cr (NP)/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

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
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06977512700015DTS, RESTORATION, PORCELAINDTS Digital Dental LabNSP2024-06-13
06977512700022DTS, RESTORATION, PORCELAINDTS Digital Dental LabNSP2024-06-13
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08936214223367Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
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08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
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08936214224104Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224128Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224142Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214225002Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214223169Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-18
08936214223206RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-18
08936214223244Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-18
08936214223268Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-18
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08936214223022Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
08936214223046RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
08936214223084Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
08936214223107RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
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