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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MIDCOURSE CORRECTIONS KIT
Access Dental Lab, LLC
100-0010
In Commercial Distribution

  • 00850007728014 ()


  • Orthodontic progressive aligner
sequential aligner system
Access Dental Lab, LLC
100-0352
In Commercial Distribution

  • 00850007728007 ()


  • Orthodontic progressive aligner
Dental retainer
STRAIGHT SMILE LLC
BYTERetainerTray
In Commercial Distribution

  • 00850017524187 ()
PRS-0063

  • Orthodontic progressive aligner
Sequential Aligners
STRAIGHT SMILE LLC
NBYTETray
In Commercial Distribution

  • 00850017524170 ()
PRS-0063

  • Orthodontic progressive aligner
Sequential Aligners
STRAIGHT SMILE LLC
HBYTETray
In Commercial Distribution

  • 00850017524163 ()
PRS-0063

  • Orthodontic progressive aligner
Inman Digital Clear Aligner
Inman Orthodontic Laboratories, Inc.
DCA253272
In Commercial Distribution

  • D141DCA2532729 ()
  • D141DCA253720 ()


  • Orthodontic progressive aligner
Clear Aligner
Creo Dent Hudson Valley, Inc.
CREOKORREKT
In Commercial Distribution

  • D124CREOKORREKT0 ()


  • Orthodontic progressive aligner
An orthodontic appliance, typically supplied in series intended to be worn while sleeping and for about one hour during the day, designed to influence the shape and or function of the stomatognathic system to correct malocclusions, e.g., underbites, overbites, cross bites, open bites, crooked teeth, and or structural flaws of teeth and or jaws. The device is self-removable, a post-treatment orthodontic retainer positioner may be included with the device. This is a reusable device.
FOREST-ONE CO., LTD.
T3-SS
In Commercial Distribution

  • 04573443678847 ()


  • Orthodontic progressive aligner
An orthodontic appliance, typically supplied in series intended to be worn while sleeping and for about one hour during the day, designed to influence the shape and or function of the stomatognathic system to correct malocclusions, e.g., underbites, overbites, cross bites, open bites, crooked teeth, and or structural flaws of teeth and or jaws. The device is self-removable, a post-treatment orthodontic retainer positioner may be included with the device. This is a reusable device.
FOREST-ONE CO., LTD.
T3-SH
In Commercial Distribution

  • 04573443678830 ()


  • Orthodontic progressive aligner
An orthodontic appliance, typically supplied in series intended to be worn while sleeping and for about one hour during the day, designed to influence the shape and or function of the stomatognathic system to correct malocclusions, e.g., underbites, overbites, cross bites, open bites, crooked teeth, and or structural flaws of teeth and or jaws. The device is self-removable, a post-treatment orthodontic retainer positioner may be included with the device. This is a reusable device.
FOREST-ONE CO., LTD.
T3-MH
In Commercial Distribution

  • 04573443678823 ()


  • Orthodontic progressive aligner
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