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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Sequential clear aligner system to straighten teeth
Precision Align LLC
1
In Commercial Distribution

  • 00860010675700 ()


  • Orthodontic progressive aligner
Product Name:LuxCreo Clear Aligner System;Model Numbers:DCA-TC;Color:colorless and transparent.
Luxcreo Inc
DCA-TC
In Commercial Distribution

  • 00860010425466 ()


  • Orthodontic progressive aligner
Product Name:LuxCreo Clear Aligner System;Model Numbers:DCA-TB;Color:colorless and transparent.
Luxcreo Inc
DCA-TB
In Commercial Distribution

  • 00860010425404 ()


  • Orthodontic progressive aligner
Partial sequential aligners
Ohlendorf Co.
EXP102
In Commercial Distribution

  • 00860013140717 ()


  • Orthodontic progressive aligner
Full arch sequential aligners
Ohlendorf Co.
FOR101
In Commercial Distribution

  • 00860013140700 ()


  • Orthodontic progressive aligner
Archform Aligners and Retainers
Archform Inc.
1
In Commercial Distribution

  • 00860012168514 ()
1

  • Orthodontic progressive aligner
Sequential aligner
Ortho Dent Laboratory Inc
7201
In Commercial Distribution

  • 00860011027201 ()


  • Orthodontic progressive aligner
No Description
VITANG TECHNOLOGY, LLC
Aligners
In Commercial Distribution

  • 00860012674619 ()


  • Orthodontic progressive aligner
BRIUS Clear Aligner
Brius Technologies Inc
1
In Commercial Distribution

  • 00860002991016 ()


  • Orthodontic progressive aligner
Voodoo Clear Aligners are clear orthodontic aligners prescribed by a clinician to treat malocclusion. The patient follows a set treatment plan designed by the provider or a third party and that produces a series of steps (or trays) that are then worn by the patient. The clinician provides periodic checkups to make sure treatment is progressing appropriately.
VOODOO MANUFACTURING, INC.
1
In Commercial Distribution

  • 00860000937801 ()


  • Orthodontic progressive aligner
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