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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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AccuPlan® System - 00810007630694

ORTHOGNATHIC, SURGICAL GUIDE
Medcad
ZB-K004
In Commercial Distribution

  • 00810007630694 ()
ZB-K004

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit

AccuPlan® System - 00810007630687

ORTHOGNATHIC, 3D PRINTED DENTAL MODELS
Medcad
ZB-K003
In Commercial Distribution

  • 00810007630687 ()
ZB-K003

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit

AccuPlan® System - 00810007630670

ORTHOGNATHIC, FINAL SPLINT
Medcad
ZB-K002
In Commercial Distribution

  • 00810007630670 ()
ZB-K002

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit

AccuPlan® System - 00810007630663

ORTHOGNATHIC, INTERMEDIATE SPLINT
Medcad
ZB-K001
In Commercial Distribution

  • 00810007630663 ()
ZB-K001

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit

AccuPlan® System - 00810007630656

ORTHOGNATHIC, SURGICAL PLANNING KIT - REPORT
Medcad
ZB-K000-R
In Commercial Distribution

  • 00810007630656 ()
ZB-K000-R

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit

AccuPlan® System - 00810007630649

ORTHOGNATHIC, SURGICAL PLANNING KIT
Medcad
ZB-K000
In Commercial Distribution

  • 00810007630649 ()
ZB-K000

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit

AccuPlan System - 00810007630533

ORTHOGNATHIC, SURGICAL PLANNING KIT - REPORT
Medcad
MC-K000-R
In Commercial Distribution

  • 00810007630533 ()
MC-K000-R

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit

ERA® - 00841549116131

Micro Dentist Tool Kit. Prosthetic Kit offers the dentist an easy solution in one small packaging. These kits are the perfect solution prosthetic dental restorations, both for a single crown and bridge restoration. Consists of prosthetic tools for prosthetic dental restorations.
STERNGOLD DENTAL LLC
811026
In Commercial Distribution

  • 00841549116131 ()


  • Surgical screwdriver, reusable

X-Guide - 00817421021435

BONE SCREW, EDX - 3.2Ø x 16mm
XNAV TECHNOLOGIES LLC
P010308
In Commercial Distribution

  • 00817421021442 ()
  • 00817421021435 ()
  • 00817421022739 ()
P010308

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable

X-Guide - 00817421021411

BONE SCREW, EDX - 3.2Ø x 8mm
XNAV TECHNOLOGIES LLC
P010307
In Commercial Distribution

  • 00817421021428 ()
  • 00817421021411 ()
  • 00817421022722 ()
P010307

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
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