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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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iTero Lumina Mobile Configuration - 00816063021438

iTero Lumina Intraoral scanner Mobile Configuration
Align Technology, Inc.
213783
In Commercial Distribution

  • 00816063021438 ()


  • Dental milling system, CAD/CAM, chairside

iTero Lumina Cart upgrade from Element Plus - 00816063021421

Upgrade kit for existing iTero users who upgrade their Plus scanner to Lumina scanner
Align Technology, Inc.
213340
In Commercial Distribution

  • 00816063021421 ()


  • Dental milling system, CAD/CAM, chairside

iTero Lumina Cart Configuration - 00816063021414

iTero Lumina Intraoral scanner Cart Configuration
Align Technology, Inc.
213782
In Commercial Distribution

  • 00816063021414 ()


  • Dental milling system, CAD/CAM, chairside

DOA Kit, Element 5D Plus Lite - 00816063021100

DOA Kits
Align Technology, Inc.
212202
In Commercial Distribution

  • 00816063021100 ()


  • Dental milling system, CAD/CAM, chairside

DOA Kit, 5D US Plus - 00816063021094

DOA Kits
Align Technology, Inc.
212270
In Commercial Distribution

  • 00816063021094 ()


  • Dental milling system, CAD/CAM, chairside

DOA Kit, 5D Plus - 00816063021087

DOA Kits
Align Technology, Inc.
212269
In Commercial Distribution

  • 00816063021087 ()


  • Dental milling system, CAD/CAM, chairside

DOA Kit, Element 2 Plus - 00816063021070

DOA Kits
Align Technology, Inc.
211789
In Commercial Distribution

  • 00816063021070 ()


  • Dental milling system, CAD/CAM, chairside

Packed iTero Mobile Computing Unit RMA 5D Plus - 00816063021063

PPC RMAs
Align Technology, Inc.
212266
In Commercial Distribution

  • 00816063021063 ()


  • Dental milling system, CAD/CAM, chairside

Packed iTero Mobile Computing Unit RMA E2 Plus - 00816063021056

PPC RMAs
Align Technology, Inc.
209875
In Commercial Distribution

  • 00816063021056 ()


  • Dental milling system, CAD/CAM, chairside

Packed iTero Computing Unit RMA 5D Plus - 00816063021049

PPC RMAs
Align Technology, Inc.
212265
In Commercial Distribution

  • 00816063021049 ()


  • Dental milling system, CAD/CAM, chairside
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