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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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PlanScan - 00858809006033

No Description
D4D TECHNOLOGIES, LLC
12395901 Scanner Tip Portrait Autoclave
Not in Commercial Distribution

  • 00858809006033 ()


  • Dental milling system, CAD/CAM, chairside

PlanScan - 00858809006026

No Description
D4D TECHNOLOGIES, LLC
12395801 Scanner Tip Landscape Autoclave
Not in Commercial Distribution

  • 00858809006026 ()


  • Dental milling system, CAD/CAM, chairside

OVO IOS - 00864206000437

OVO IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impression, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. OVO IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
3D IMAGING AND SIMULATION CORP. AMERICAS
IOS-FP-71-003
In Commercial Distribution

  • 00864206000437 ()


  • Dental milling system, CAD/CAM, chairside

Heron IOS - 00864206000406

Heron IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Heron IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
3D IMAGING AND SIMULATION CORP. AMERICAS
IOS-FP-71-001
In Commercial Distribution

  • 00864206000406 ()


  • Dental milling system, CAD/CAM, chairside

Retitrack - 00860011292104

Eye movement monitor
C. Light Technologies, Inc.
CR1
In Commercial Distribution

  • 00860011292111 ()
  • 00860011292104 ()


  • Eye/eyelid movement monitoring spectacles/goggles

Gro3X DIU - 00860006572501

Gro3X DIU system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Gro3X DIU system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
Gro3x, Inc.
DIU-3D-71-001
In Commercial Distribution

  • 00860006572501 ()


  • Dental milling system, CAD/CAM, chairside

TRIOS - 05902768365580

Calibaration kit for TRIOS Color to measure shades
3shape Trios A/S
TRIOS Color Calibration Kit
Not in Commercial Distribution

  • 05902768365580 ()


  • Dental milling system, CAD/CAM, chairside

TRIOS - 05902768365573

Autoclavable scanner tip for TRIOS Color
3shape Trios A/S
TRIOS Color Scanner Tip
Not in Commercial Distribution

  • 05902768365573 ()


  • Dental milling system, CAD/CAM, chairside

TRIOS - 05902768365528

Autoclavable scanner tip for TRIOS Standard
3shape Trios A/S
TRIOS Standard- Scanner Tip
Not in Commercial Distribution

  • 05902768365528 ()


  • Dental milling system, CAD/CAM, chairside

TRIOS 3 - 05902768365450

Enables TRIOS® 3 systems to measure shades.
3shape Trios A/S
TRIOS 3 Color Calibration Kit
Not in Commercial Distribution

  • 05902768365450 ()


  • Dental milling system, CAD/CAM, chairside
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