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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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Planmeca Emerald S - 00858809006224

Qty 1 - 15610003 - Emerald S Scanner (US) Qty 1 - 15600141 - Emerald S Scanner Accessories Qty 1 - 15693001 Cariosity Tip
D4D TECHNOLOGIES, LLC
15600140 Emerald S Scanner Kit, Cariosity, US
Not in Commercial Distribution

  • 00858809006170 ()
  • 00858809006224 ()


  • Dental caries detector, optical induced fluorescence
  • Dental milling system, CAD/CAM, chairside

NewTom - 08033837932970

The device is an optical impression system. It is used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer-aided design (CAD) and computer-aided manufacturing (CAM) of dental restorative prosthetic devices.
CEFLA SOCIETA' COOPERATIVA
NewTom IOS
In Commercial Distribution

  • 08033837932970 ()
70960000

  • Intraoral optical scanning system
  • Dental milling system, CAD/CAM, chairside

AccuPlan System - 00810007632186

MIDFACE RECONSTRUCTION, TITANIUM HYBRID SURGICAL GUIDE
Medcad
ZB-KT021-H
In Commercial Distribution

  • 00810007632186 ()
ZB-KT021-H

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

AccuPlan System - 00810007632179

MIDFACE RECONSTRUCTION, TITANIUM SURGICAL GUIDE
Medcad
ZB-KT021
In Commercial Distribution

  • 00810007632179 ()
ZB-KT021

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

AccuPlan System - 00810007632162

MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT, W/ TITANIUM HYBRID GUIDES
Medcad
ZB-KT020-H
In Commercial Distribution

  • 00810007632162 ()
ZB-KT020-H

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

AccuPlan System - 00810007632155

MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT, W/ TITANIUM GUIDES
Medcad
ZB-KT020
In Commercial Distribution

  • 00810007632155 ()
ZB-KT020

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

AccuPlan System - 00810007632087

MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT, W/ TITANIUM HYBRID GUIDES
Medcad
ZB-KT010-H
In Commercial Distribution

  • 00810007632087 ()
ZB-KT010-H

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

AccuPlan System - 00810007632070

MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT, W/ TITANIUM GUIDES
Medcad
ZB-KT010
In Commercial Distribution

  • 00810007632070 ()
ZB-KT010

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

AccuPlan System - 00810007631677

MIDFACE RECONSTRUCTION, TITANIUM HYBRID SURGICAL GUIDE
Medcad
MC-KT021-H
In Commercial Distribution

  • 00810007631677 ()
MC-KT021-H

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

AccuPlan System - 00810007631646

MIDFACE RECONSTRUCTION, TITANIUM SURGICAL GUIDE
Medcad
MC-KT021
In Commercial Distribution

  • 00810007631646 ()
MC-KT021

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