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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ALIGNERS - MFD - CARRIER (ZENDURA ROLL)
ORMCO CORPORATION
728-3007
In Commercial Distribution

  • 00889989087611 ()


  • Orthodontic progressive aligner
XL ALIGNER KIT 1 ALT
ORMCO CORPORATION
728-3004
In Commercial Distribution

  • 00889989087604 ()


  • Orthodontic progressive aligner
ALIGNER SHEETS - PRO ALIGNER X – Ø 125 X 1 MM- PCT 10 UN
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
30.11.0067
In Commercial Distribution

  • 07908470707197 ()
30.11.0067

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

  • 00817645020177 ()


  • Orthodontic progressive aligner
ALIGNER SHEETS- PRO ALIGNER X- Ø 125 X 0,76 MM- PCT 25 UN
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
30.11.0053
In Commercial Distribution

  • 07898488900614 ()
30.11.0053

  • Orthodontic progressive aligner
DigiLine Aligner
PARK DENTAL RESEARCH CORP
DGL-IAL
In Commercial Distribution

  • D769DGLIAL0 ()


  • Orthodontic progressive aligner
Park Dental Aligner
PARK DENTAL RESEARCH CORP
PDA-IAL
In Commercial Distribution

  • D769PDAIAL0 ()
PDA-IAL

  • Orthodontic progressive aligner
The Invisalign System with Mandibular advancement - precision wings is used to treat patients with Class I and Class II malocclusion, severe open bit, severe overjet, deep bit, skeletally narrow jaw, and dental prostheses/implants, and/or those who require surgical correction.
Align Technology, Inc.
222716
In Commercial Distribution

  • 00816063022152 ()


  • Orthodontic progressive aligner
The Invisalign System with Mandibular advancement - enhanced precision wings (EPW) is used to treat patients with Class I and Class II malocclusion, severe open bit, severe overjet, deep bit, skeletally narrow jaw, and dental prostheses/implants, and/or those who require surgical correction. The EPW are modified precision wings with longer and curved wings, with an added rib on buccal side, which are designed to optimize mandibular advancement.
Align Technology, Inc.
222715
In Commercial Distribution

  • 00816063022145 ()


  • Orthodontic progressive aligner
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (MAOB) is used to introduce mandibular skeletal changes in the treatment of Class I and Class II malocclusion, severe open bite, severe overjet, deep bite, skeletally narrow jaw, and those who require surgical correction.
Align Technology, Inc.
221572
In Commercial Distribution

  • 00816063022091 ()


  • Orthodontic progressive aligner
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