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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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IvoBase HI / IvoBase Hybrid - 07615208009446

IvoBase HI Kit 20 Pink-V Implant
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
628892AN
In Commercial Distribution

628892AN

  • Denture base resin kit

IPS Empress Direct - 07615208009347

Empress Direct Refill 1x3g Trans 20
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
627248AN
In Commercial Distribution

627248AN

  • Dental composite resin

IPS Classic - 07615208407792

IPS Classic Add-On Powder 20 g
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
541671
In Commercial Distribution

541671

  • Dental appliance fabrication material, ceramic

Integra® Miltex® - 10381780510529

Aluminum Shell, Size #20 - 100 Pack
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
505-21130
Not in Commercial Distribution

  • H834505211301 ()
  • 10381780510529 ()
  • 00381780510522 ()
505-21130

  • Dental impression tray, reusable

Integra® Miltex® - 10381780510369

Test Hedstrom Files, #20 - 6 Pack
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-11301
Not in Commercial Distribution

  • H834012113011 ()
  • 10381780510369 ()
  • 00381780510362 ()
012-11301

  • Manual endodontic file/rasp, single-use

Integra® Miltex® - 10381780482840

Onyx-H™ Hedstrom Files #20 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-15101
Not in Commercial Distribution

  • H834012151011 ()
  • 10381780482840 ()
  • 00381780482843 ()
012-15101

  • Manual endodontic file/rasp, single-use

Integra® Miltex® - 10381780482789

Onyx-H™ Hedstrom Files #20 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-15081
Not in Commercial Distribution

  • H834012150811 ()
  • 10381780482789 ()
  • 00381780482782 ()
012-15081

  • Manual endodontic file/rasp, single-use

Integra® Miltex® - 10381780481881

Union Broach® Reamers #20 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12184
Not in Commercial Distribution

  • H834012121841 ()
  • 10381780481881 ()
  • 00381780481884 ()
012-12184

  • Manual endodontic file/rasp, single-use

Integra® Miltex® - 10381780481744

Union Broach® Reamers #20 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12064
Not in Commercial Distribution

  • H834012120641 ()
  • 10381780481744 ()
  • 00381780481747 ()
012-12064

  • Manual endodontic file/rasp, single-use

Integra® Miltex® - 10381780481607

Union Broach® Reamers #20 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12005
Not in Commercial Distribution

  • H834012120051 ()
  • 10381780481607 ()
  • 00381780481600 ()
012-12005

  • Manual endodontic file/rasp, single-use
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