FDA.report

CAD/CAM Full Denture Resin

Primary DI
06975031821143
Brand
CAD/CAM Full Denture Resin
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
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NSLDentures, Full

Product Code Classifications

CodeDeviceSpecialtyClass
NSLDentures, FullUnknownN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06975031821143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06975031821143069750318211436975031821143

GMDN Terms

TermDefinition
Complete upper dentureA custom-made artificial replacement for all teeth in the upper jaw (maxilla) carried on a removable plate or frame which is supported by surrounding soft and hard tissues of the oral cavity. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)].

Sterilization Methods

Method
Ozone;Ultraviolet Light

Regulatory Flags

DUNS number
560456141
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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

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06977512700046DTS, DENTURES, FULLDTS Digital Dental LabNSL2024-06-13
06977512700091DTS, DENTURES, FULLDTS Digital Dental LabNSL2024-06-13
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D101SGI870Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2022-06-01
D101SGI160Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2022-04-28
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D101SGI220Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2022-04-28
D101SGI50Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2022-04-28
D101SGI750Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2022-04-27
D101SGI770Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2022-04-27
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06972677873291Denture, restoration, orthodonticModern Dental Laboratory (DG) Co., Ltd.NSL2020-07-24
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