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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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Xantasil - J014660521020

Xantasil Cartridge Fast Set 6 x 50ML
Kulzer GmbH
66052102
In Commercial Distribution

  • J014660521020 ()
66052102

  • Silicone dental impression material

Xantasil - J014660521010

Xantasil Dynamix Fast Set 2 x 380ML
Kulzer GmbH
66052101
In Commercial Distribution

  • J014660521010 ()
66052101

  • Silicone dental impression material

PalaXpress ultra clear,12000g - J014660519030

Resin, denture, relining, repairing,rebasing
Kulzer GmbH
66051903
Not in Commercial Distribution

  • J014660519030 ()
66051903

  • Dental appliance fabrication material, thermoplastic

PalaXpress ultra pink opaque, 12000g - J014660519020

Resin, denture, relining, repairing,rebasing
Kulzer GmbH
66051902
Not in Commercial Distribution

  • J014660519020 ()
66051902

  • Dental appliance fabrication material, thermoplastic

PalaXpress ultra pink live, 12000g - J014660518010

Resin, denture, relining, repairing,rebasing
Kulzer GmbH
66051801
Not in Commercial Distribution

  • J014660518010 ()
66051801

  • Dental appliance fabrication material, thermoplastic

PalaXpress ultra, R50 veined, 12000g - J014660502120

Resin, denture, relining, repairing,rebasing
Kulzer GmbH
66050212
Not in Commercial Distribution

  • J014660502120 ()
66050212

  • Dental appliance fabrication material, thermoplastic

Venus Bulk Fill Syr Refill 1 x 1,8G - J014660467950

Varnish, cavity
Kulzer GmbH
66046795
Not in Commercial Distribution

  • J014660467950 ()
66046795

  • Dental cavity varnish

Venus Bulk Fill Syringe Intro Kit A3+TE - J014660467940

Varnish, cavity
Kulzer GmbH
66046794
Not in Commercial Distribution

  • J014660467940 ()
66046794

  • Dental cavity varnish

Venus Bulk Fill Syringe Intro Kit A3+SE - J014660467930

Varnish, cavity
Kulzer GmbH
66046793
Not in Commercial Distribution

  • J014660467930 ()
66046793

  • Dental cavity varnish

PalaXpress ultra, pink vein., 12000g Pu - J014660462220

Resin, denture, relining, repairing,rebasing
Kulzer GmbH
66046222
Not in Commercial Distribution

  • J014660462220 ()
66046222

  • Dental appliance fabrication material, thermoplastic
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