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 Class Implantable

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SPECIALTY APPLIANCES, LLC
700092
In Commercial Distribution

  • D8197000920 ()


  • Orthodontic progressive aligner
Clear Image Aligner Refinement (Z-FLX): Dual
SPECIALTY APPLIANCES, LLC
700091
In Commercial Distribution

  • D8197000910 ()


  • Orthodontic progressive aligner
Clear Image Aligner Refinement (Z-FLX): Lower
SPECIALTY APPLIANCES, LLC
700090
In Commercial Distribution

  • D8197000900 ()


  • Orthodontic progressive aligner
Clear Image Aligner Refinement (Z-FLX): Upper
SPECIALTY APPLIANCES, LLC
700089
In Commercial Distribution

  • D8197000890 ()


  • Orthodontic progressive aligner
Clear Image Aligner Advanced (Z-FLX): Dual
SPECIALTY APPLIANCES, LLC
700088
In Commercial Distribution

  • D8197000880 ()


  • Orthodontic progressive aligner
Clear Image Aligner Advanced (Z-FLX): Lower
SPECIALTY APPLIANCES, LLC
700087
In Commercial Distribution

  • D8197000870 ()


  • Orthodontic progressive aligner
Clear Image Aligner Advanced (Z-FLX): Upper
SPECIALTY APPLIANCES, LLC
700086
In Commercial Distribution

  • D8197000860 ()


  • Orthodontic progressive aligner
Clear Image Aligner Plus (Z-FLX): Dual
SPECIALTY APPLIANCES, LLC
700085
In Commercial Distribution

  • D8197000850 ()


  • Orthodontic progressive aligner
Clear Image Aligner Plus (Z-FLX): Lower
SPECIALTY APPLIANCES, LLC
700084
In Commercial Distribution

  • D8197000840 ()


  • Orthodontic progressive aligner
Clear Image Aligner Plus (Z-FLX): Upper
SPECIALTY APPLIANCES, LLC
700083
In Commercial Distribution

  • D8197000830 ()


  • Orthodontic progressive aligner
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