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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Reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays.
Curetis GmbH
Acuitas AMR Gene Panel Reagent Kit
Not in Commercial Distribution

12002

  • Nucleic acid amplification mastermix kit IVD
Kit of 12 disposable Unyvero LRT Cartridges, including sample tubes, sample tube caps and sample transfer tools, for testing 12 patient samples in total. Each sample also requires 1 Unyvero M1 Master Mix Tube for processing (not contained in this kit)
Curetis GmbH
LRT Cartridge Kit
Not in Commercial Distribution

  • 04260364750034 ()
10049

  • Multiple respiratory disease-associated bacteria/antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique
Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets. Rely•a•Bond® is a No Mix Bonding System that sets on contact. This is the Rely A Bond 14g Adhesive paste in Tips.
RELIANCE ORTHODONTIC PRODUCTS INC
RPT
In Commercial Distribution

  • D798RPT1 ()
  • D798RPT0 ()
  • D798RPT2 ()
RPT

  • Orthodontic bracket adhesive
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HTX Shaded Group WMX5
Not in Commercial Distribution

  • D040742621 ()
74262

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HTX Shaded Group WMX5
Not in Commercial Distribution

  • D040742611 ()

  • 20mm X 98mm
74261

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HTX Shaded Group WMX5
Not in Commercial Distribution

  • D040742591 ()

  • 16mm X 98mm
74259

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HTX Shaded Group WMX5
Not in Commercial Distribution

  • D040742581 ()

  • 14mm X 98mm
74258

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HTX Shaded Group WMX5
Not in Commercial Distribution

  • D040742571 ()

  • 12mm X 98mm
74257

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HTX Shaded Group DMX5
Not in Commercial Distribution

  • D040742561 ()

  • 10mm X 98mm
74256

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HTX Shaded Group WMX4
Not in Commercial Distribution

  • D040742551 ()

  • 25mm X 98mm
74255

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HTX Shaded Group WMX4
Not in Commercial Distribution

  • D040742541 ()

  • 20mm X 98mm
74254

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HTX Shaded Group WMX4
Not in Commercial Distribution

  • D040742521 ()

  • 16mm X 98mm
74252

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HTX Shaded Group WMX4
Not in Commercial Distribution

  • D040742511 ()

  • 14mm X 98mm
74251

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HTX Shaded Group WMX4
Not in Commercial Distribution

  • D040742501 ()

  • 12mm X 98mm
74250

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HTX Shaded Group WMX4
Not in Commercial Distribution

  • D040742491 ()

  • 10mm X 98mm
74249

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HTX Shaded Group WMX3
Not in Commercial Distribution

  • D040742481 ()

  • 25mm X 98mm
74248

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HTX Shaded Group WMX3
Not in Commercial Distribution

  • D040742471 ()

  • 20mm X 98mm
74247

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HTX Shaded Group WMX3
Not in Commercial Distribution

  • D040742451 ()

  • 16mm X 98mm
74245

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HTX Shaded Group WMX3
Not in Commercial Distribution

  • D040742441 ()

  • 14mm X 98mm
74244

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HTX Shaded Group WMX3
Not in Commercial Distribution

  • D040742431 ()

  • 12mm X 98mm
74243

  • Custom-made dental crown, ceramic
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