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

  • D9393DS080 ()


  • Orthodontic progressive aligner
Orthodontic appliance system, progressive FDA PT: HJDC
Digital Orthodontic Care
Aligners
In Commercial Distribution

  • D918SCA2 ()
  • D918SCA1 ()
  • D918SCA0 ()


  • Orthodontic progressive aligner
FXTetra Clear Aligner 2.0
ORTHOFX
019
In Commercial Distribution

  • 00860003321799 ()


  • Orthodontic progressive aligner
No Description
ORTHOFX
013
In Commercial Distribution

  • 00860003321782 ()


  • Orthodontic progressive aligner
OrthoFX Rescue aligner. Specialized purpose of bringing off track treatment back on track.
ORTHOFX
RA1
In Commercial Distribution

  • 00860003321751 ()


  • Orthodontic progressive aligner
Updated UDI submission for Zendura material aligners.
ORTHOFX
FXTetra
In Commercial Distribution

  • 00860003321706 ()


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

  • 00860002991016 ()


  • Orthodontic progressive aligner
The uLab Systems Dental Aligner Kit 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.
FG0094
In Commercial Distribution

  • 00860002380094 ()


  • Orthodontic progressive aligner
No Description
Ulab Systems, Inc.
FG0094 Rev. D
In Commercial Distribution

  • 00860002380063 ()


  • Orthodontic progressive aligner
Discontinued product code.
DERBY DENTAL LABORATORY, INC
POCA
Not in Commercial Distribution

  • 00860002302355 ()


  • Orthodontic progressive aligner
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