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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ClearArc™ Aligners FULL
ORTHO ORGANIZERS, INC.
130-FULL
Not in Commercial Distribution

  • 00190707086718 ()


  • Orthodontic progressive aligner
No Description
U Smile Dental LLC
LX-A
In Commercial Distribution

  • 90860006415429 ()


  • Orthodontic progressive aligner
No Description
ORTHOFX
Z1
Not in Commercial Distribution

  • 18600033217063 ()


  • Orthodontic progressive aligner
1. Description eCligner® is thin, transparent and removable orthodontic aligner. 2. Explanation 2.1 eCligner®, developed by 3D digital technology eCligner® is clear aligner made by 3D digital CAD/CAM system. Self-developed 3D simulation program is yearly upgraded with latest technology. All that’s needed to make whole set of eCligner® for patient is only one stone model. 2.2 eCligner® provides aesthetic and comfortable orthodontic treatment. Transparent aligner won’t be noticed by others and can temporarily be removed at one’s convenience. Recommended aligner wear time is 17 hours daily for the best treatment result. 2.3 eCligner® system process eCligner® has combined dental orthodontic concept and principles into 3D simulation system. Orthodontic professionals produce aligners based on such system, calibrating teeth movement and influences that affect teeth and even tissues. 1) eCligner® aligners consists of 3 aligners per step. (Patient should wear Soft,Medium,Hard aligners for a week each) 2) Patient should wear each aligners 17~19 hours daily. 3) Aligner enables gradual teeth movement per each step. 4) Advise patient to visit your clinic and check treatment progress every 3 weeks
E-Clear International Co., Ltd.
1.0
In Commercial Distribution

  • 38800018800035 ()
  • 18800018800918 ()
  • 18800018800017 ()
  • 38800018800028 ()
  • 28800018800021 ()
  • 18800018800116 ()
  • 18800018800215 ()
  • 18800018800314 ()
  • 18800018800413 ()
  • 18800018800512 ()
  • 18800018800611 ()
  • 18800018800710 ()
  • 18800018800819 ()
  • 28800018800014 ()


  • Orthodontic progressive aligner
A series of preformed teeth aligners or positioners, worn in succession and changed every few weeks, designed to influence the shape and/or function of the stomatognathic system; often used to impact a patient's appearance and self image. It is typically custom-made using computer-generated modelling based on an initial oral impression, and a consultation with an orthodontist. It is typically made of a clear hard plastic, e.g., a thermoformed polycarbonate (PC). It is typically used to correct malocclusions such as underbites, overbites, cross bites and open bites, or crooked teeth and various other flaws of teeth and jaws, whether cosmetic or structural. This is a single-use device.
New England Orthodontic Lab
1021
In Commercial Distribution

  • 00810064700002 ()
1021

  • Orthodontic progressive aligner
Dental Aligners
Six Month Smiles
800-ALN
In Commercial Distribution

  • 00817645020177 ()


  • Orthodontic progressive aligner
Reveal™ Aligners - Refinements
HENRY SCHEIN, INC.
1359850
In Commercial Distribution

  • 10304040114152 ()
  • 00304040114155 ()
1359850

  • Orthodontic progressive aligner
Reveal™ Aligners - Refinements
HENRY SCHEIN, INC.
1359823
In Commercial Distribution

  • 10304040114145 ()
  • 00304040114148 ()
1359823

  • Orthodontic progressive aligner
Reveal™ Aligners - Refinements
HENRY SCHEIN, INC.
1359791
In Commercial Distribution

  • 10304040114138 ()
  • 00304040114131 ()
1359791

  • Orthodontic progressive aligner
Reveal™ Aligners - Refinements
HENRY SCHEIN, INC.
1359851
In Commercial Distribution

  • 10304040114121 ()
  • 00304040114124 ()
1359851

  • Orthodontic progressive aligner
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