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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3M™ Clarity™ Aligner Replacement - Lost/Damaged
3M UNITEK CORPORATION
358-998
In Commercial Distribution

  • 00652221236432 ()
358-998

  • Orthodontic progressive aligner
3M™ Clarity™ Aligner Refinement - Single Arch
3M UNITEK CORPORATION
358-472
In Commercial Distribution

  • 00652221236425 ()
358-472

  • Orthodontic progressive aligner
3M™ Clarity™ Aligner Refinement - Dual Arch
3M UNITEK CORPORATION
358-471
In Commercial Distribution

  • 00652221236418 ()
358-471

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

  • 00860003321799 ()


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

  • 00860003321706 ()


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

  • 00860002302355 ()


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

  • 00860002302317 ()


  • Orthodontic progressive aligner
Discontinued - No longer in use.
DERBY DENTAL LABORATORY, INC
01
Not in Commercial Distribution

  • 00860002302300 ()


  • Orthodontic progressive aligner
No Description
Orthly, Inc.
K173785
In Commercial Distribution

  • 00860006891206 ()


  • Orthodontic progressive aligner
Tru-Smile Clear Aligner
Phase Ortho, Inc.
TSCA
In Commercial Distribution

  • 00860006274368 ()


  • Orthodontic progressive aligner
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