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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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.
T1-SH
In Commercial Distribution

  • 04573443678793 ()


  • 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.
T1-MS
In Commercial Distribution

  • 04573443678786 ()


  • 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.
T1-MH
In Commercial Distribution

  • 04573443678779 ()


  • 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.
T1-LH
In Commercial Distribution

  • 04573443678762 ()


  • Orthodontic progressive aligner
Orthodontic plastic aligner
3D SMILE USA, INC
3DS08
In Commercial Distribution

  • D9393DS080 ()


  • Orthodontic progressive aligner
The Concinnity Aligners™ are a custom clear aligner system. They are a series of doctor-approved clear plastic removable aligners that are used as an alternative to traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original misalignment to their final treated position for improved dental alignment. Intended Use / Indications for Use: The Concinnity Aligners™ is intended for orthodontic treatment and correction of misaligned and maloccluded permanent teeth (i.e. all second molars).
DRAKE PRECISION DENTAL LABORATORY, INC.
CA0000000001
In Commercial Distribution

  • 00850028222003 ()


  • Orthodontic progressive aligner
Aligner, Sequential
EON DENTAL JORDAN (FREE ZONE)
Eon Aligner
In Commercial Distribution

  • 06254000529014 ()


  • Orthodontic progressive aligner
The uLab Systems Reva Disc is a non-sterile sheet of thermoplastic intended to be used by a dental practitioner to fabricate polymer orthodontic and dental appliances. The sheets of material are heated by the dental practitioner in an office setting and then vacuum-formed over a dental impression of the patient’s teeth. Once formed, the appliance is then trimmed to fit the patient.
Ulab Systems, Inc.
FG0010
In Commercial Distribution

  • 00860461001790 ()


  • Orthodontic progressive aligner
The Clearjoy Dental Aligner kit is a line extension of the uLab Systems Dental Aligner Kit and is an orthodontic treatment system, that consists of doctor-prescribed, clear, thin, plastic removable aligners. Patients are seen in a dental office where a dental professional (dentist/orthodontist) scans or takes a physical impression of the teeth, which is then used to fabricate the aligners. The aligners are designed by dental professionals using uLab Systems technology. The aligners are made of aesthetic and medical grade materials. During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient’s teeth gradually to the ideal position.
Ulab Systems, Inc.
1
Not in Commercial Distribution

  • 00860461001714 ()
FG0094-05

  • 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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