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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No Description
SPECIALTY APPLIANCES, LLC
700002
In Commercial Distribution

  • D8197000020 ()


  • Orthodontic progressive aligner
No Description
SPECIALTY APPLIANCES, LLC
700001
In Commercial Distribution

  • D8197000010 ()


  • Orthodontic progressive aligner
Single Arch Aligner
SPECIALTY APPLIANCES, LLC
700000
In Commercial Distribution



  • Orthodontic progressive aligner
The ClearCorrect device is fabricated of clear thin thermoformed polyurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner.
Clearcorrect Operating, LLC
Aligner (Single-layer)
In Commercial Distribution

REF-05

  • Orthodontic progressive aligner
The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite resin in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner
Clearcorrect Operating, LLC
Aligner (Multi-layer)
In Commercial Distribution

REF03

  • Orthodontic progressive aligner
The ClearCorrect device is fabricated of clear thin thermoformed polyurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner.
Clearcorrect Operating, LLC
Aligner (Single-layer)
Not in Commercial Distribution

  • D865REF00051 ()
REF-05

  • Orthodontic progressive aligner
The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite resin in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner
Clearcorrect Operating, LLC
Aligner (Multi-layer)
Not in Commercial Distribution

  • D865REF00031 ()
REF-03

  • Orthodontic progressive aligner
The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner.
Clearcorrect Operating, LLC
Aligner (Single-Layer)
Not in Commercial Distribution

  • D865REF00011 ()
REF-01

  • Orthodontic progressive aligner
The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner.
Clearcorrect Operating, LLC
MFG-0100 5.0
Not in Commercial Distribution

  • D865REF0001 ()
REF-01

  • Orthodontic progressive aligner
No Description
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
5100600
Not in Commercial Distribution

  • D82851006000 ()


  • Orthodontic progressive aligner
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