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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 Size Device Size Type Device Class Implantable

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TK-98 L Synea Vision - J021300190001

Synea Vision Highspeed Handpiece
W & H Dentalwerk Bürmoos GmbH
30019000
In Commercial Distribution

  • J021300190001 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic

TK-97 LM Synea Vision - J021300180001

Synea Vision Highspeed Handpiece
W & H Dentalwerk Bürmoos GmbH
30018000
In Commercial Distribution

  • J021300180000 ()
  • J021300180001 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic

TK-97 L Synea 500 - J021300170011

Synea High Speed Handpiece
W & H Dentalwerk Bürmoos GmbH
30017001
Not in Commercial Distribution

  • J021300170010 ()
  • J021300170011 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic

TK-97 L Synea Vision - J021300170001

Synea Vision Highspeed Handpiece
W & H Dentalwerk Bürmoos GmbH
30017000
In Commercial Distribution

  • J021300170001 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic

TK-94 L Synea 500 - J021300160011

Synea Highspeed Handpiece
W & H Dentalwerk Bürmoos GmbH
30016001
Not in Commercial Distribution

  • J021300160010 ()
  • J021300160011 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic

TK-94 L Synea Vision Highspeed Handpiece - J021300160001

Highspeed Handpiece
W & H Dentalwerk Bürmoos GmbH
30016000
In Commercial Distribution

  • J021300160001 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic

HG-43 A Synea Fusion - J021300130011

Synea Handpiece Attachment
W & H Dentalwerk Bürmoos GmbH
30013001
Not in Commercial Distribution

  • J021300130010 ()
  • J021300130011 ()


  • Dental surgical power tool motorized handpiece/set, electric

HG-43 A Synea Fusion Handpiece 1:1 - J021300130001

Synea Handpiece Attachment
W & H Dentalwerk Bürmoos GmbH
30013000
In Commercial Distribution

  • J021300130001 ()


  • Dental surgical power tool motorized handpiece/set, electric

WG-66 A Synea Fusion - J021300120011

Synea Handpiece Attachment
W & H Dentalwerk Bürmoos GmbH
30012001
Not in Commercial Distribution

  • J021300120010 ()
  • J021300120011 ()


  • Dental surgical power tool motorized handpiece/set, electric

WG-66 A Synea Fusion 2:1 - J021300120001

Synea Contra-angle Handpiece
W & H Dentalwerk Bürmoos GmbH
30012000
In Commercial Distribution

  • J021300120001 ()


  • Dental surgical power tool motorized handpiece/set, electric
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