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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Restoration, splint - 06972677873482

No Description
Modern Dental Laboratory (DG) Co., Ltd.
348
In Commercial Distribution

  • 06972677873499 ()
  • 06972677873482 ()


  • Custom-made dental crown, polymer
  • Custom-made dental crown, metal/polymer
  • Dental bridge, metal-polymer
  • Dental bridge, polymer
  • Dental veneer, professional
  • Resin dental inlay
  • Custom-made dental crown, ceramic
  • Dental bridge, ceramic
  • Ceramic dental inlay
  • Removable dental occlusal splint, preformed
  • Orthodontic retainer

Restoration - 06972677873208

No Description
Modern Dental Laboratory (DG) Co., Ltd.
320
In Commercial Distribution

  • 06972677873215 ()
  • 06972677873208 ()


  • Custom-made dental crown, metal
  • Dental casting noble alloy
  • Ceramic dental inlay
  • Gold dental inlay
  • Custom-made dental crown, metal/polymer
  • Custom-made dental crown, polymer
  • Dental bridge, metal-polymer
  • Dental bridge, polymer
  • Dental veneer, professional
  • Resin dental inlay
  • Custom-made dental crown, ceramic
  • Dental bridge, ceramic

Access SARS-CoV-2 IgG II - 15099590742744

The Access SARS-CoV-2 IgG II assay is a paramagnetic particle, chemiluminescent immunoassay intended for the semi-quantitative and qualitative detection of IgG antibodies to SARS-CoV-2 in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate). The Access SARS-CoV-2 IgG II assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Access SARS-CoV-2 IgG II should not be used to diagnose or exclude acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests. The Access SARS-CoV-2 IgG II assay is only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69057
In Commercial Distribution

  • 15099590742744 ()
C69057

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Denture, restoration, splint - 06972677874120

No Description
Modern Dental Laboratory (DG) Co., Ltd.
412
In Commercial Distribution

  • 06972677874137 ()
  • 06972677874120 ()


  • Dental bridge, metal-polymer
  • Complete upper denture
  • Complete lower denture
  • Custom-made dental crown, metal/polymer
  • Custom-made dental crown, polymer
  • Removable dental occlusal splint, preformed
  • Dental bridge, polymer
  • Dental veneer, professional
  • Orthodontic retainer
  • Resin dental inlay
  • Custom-made dental crown, ceramic
  • Dental bridge, ceramic
  • Ceramic dental inlay

Denture, Restoration - 08936214224104

No Description
ACESO DENTAL LABORATORY COMPANY LIMITED
410
In Commercial Distribution

  • 08936214224111 ()
  • 08936214224104 ()


  • Dental bridge, polymer
  • Dental casting noble alloy
  • Custom-made dental crown, metal
  • Gold dental inlay
  • Complete upper denture
  • Complete lower denture
  • Custom-made dental crown, metal/polymer
  • Custom-made dental crown, polymer
  • Ceramic dental inlay
  • Dental bridge, metal-polymer
  • Dental veneer, professional
  • Custom-made dental crown, ceramic
  • Resin dental inlay
  • Dental bridge, ceramic

Denture, restoration - 06972677874168

No Description
Modern Dental Laboratory (DG) Co., Ltd.
416
In Commercial Distribution

  • 06972677874175 ()
  • 06972677874168 ()


  • Gold dental inlay
  • Dental casting noble alloy
  • Custom-made dental crown, metal
  • Complete upper denture
  • Custom-made dental crown, ceramic
  • Complete lower denture
  • Custom-made dental crown, metal/polymer
  • Custom-made dental crown, polymer
  • Dental bridge, metal-polymer
  • Dental bridge, polymer
  • Dental veneer, professional
  • Resin dental inlay
  • Dental bridge, ceramic
  • Ceramic dental inlay

Denture, Restoration - 08936214221202

No Description
ACESO DENTAL LABORATORY COMPANY LIMITED
120
In Commercial Distribution

  • 08936214221219 ()
  • 08936214221202 ()


  • Partial denture
  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic

Denture, restoration - 06972677871327

No Description
Modern Dental Laboratory (DG) Co., Ltd.
132
In Commercial Distribution

  • 06972677871334 ()
  • 06972677871327 ()


  • Partial denture
  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic

Denture, restoration, splint - 06972677875028

No Description
Modern Dental Laboratory (DG) Co., Ltd.
502
In Commercial Distribution

  • 06972677875035 ()
  • 06972677875028 ()


  • Gold dental inlay
  • Dental casting noble alloy
  • Custom-made dental crown, metal
  • Complete upper denture
  • Dental bridge, ceramic
  • Orthodontic retainer
  • Complete lower denture
  • Custom-made dental crown, ceramic
  • Custom-made dental crown, metal/polymer
  • Custom-made dental crown, polymer
  • Dental bridge, metal-polymer
  • Removable dental occlusal splint, preformed
  • Dental bridge, polymer
  • Ceramic dental inlay
  • Dental veneer, professional
  • Resin dental inlay

Denture, restoration - 06972677871105

No Description
Modern Dental Laboratory (DG) Co., Ltd.
110
In Commercial Distribution

  • 06972677871112 ()
  • 06972677871105 ()


  • Complete lower denture
  • Complete upper denture
  • Custom-made dental crown, metal/ceramic
  • Dental bridge, metal-ceramic
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