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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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Utilizing high quality bipolar surface electrodes, surface EMG data can be taken from up to eight muscle sites simultaneously and in real time. The program permits taking electromyography data either at rest or in function. All eight channels may be displayed simultaneously, for a period of 15 seconds (one visual screen width). The K7/EMG signal processing circuitry provides unsurpassed protection against system noise or motion artifact. The patient education mode permits quick and easy patient education as to status of masticatory muscles.
MYOTRONICS NOROMED, INC
K7/EMG
In Commercial Distribution

  • D07920978 ()
  • D79209930 ()


  • Jaw physiology evaluation system
TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint, enabling simultaneous, bilateral capture of tissue vibrations emanating from joint sounds. Vibration (sound) data is correlated to vertical dimension of opening and closing, providing clinicians with valuable information to aid in assessing the status of articular disk and joint function.
MYOTRONICS NOROMED, INC
K7/ESG
In Commercial Distribution

  • D0792009780 ()
  • D79209750 ()


  • Jaw physiology evaluation system
Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE) thin film, Cytoflex® Tef-Guard® has a surface texture and porosity suitable for adhesion of host cells to the material while blocking passage and integration of bacteria within the interstices of the material. The supple membrane conforms easily to tissue contours, and yet offers sufficient stiffness to maintain a space over the bony defect. The micro porous surface is designed to improve flap attachment but prevent tissue and bacteria ingrowth. Cytoflex® Tef-Guard® is for use as a barrier membrane for guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE), the textured version of Cytoflex® Tef-Guard® has superficial macro texture overlapping the micro pore texture on both surfaces. The cellular level micro texture is invisible to the naked eye, but can be seen at high magnifications. The macro texture provides additional grips for flap attachment.
UNICARE BIOMEDICAL INC.
TEX-200
In Commercial Distribution

  • D767C0402010 ()
  • D767C0402051 ()
C04-0201

  • Pliable-polymer dental regeneration membrane, non-bioabsorbable
Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE) thin film, Cytoflex® Tef-Guard® has a surface texture and porosity suitable for adhesion of host cells to the material while blocking passage and integration of bacteria within the interstices of the material. The supple membrane conforms easily to tissue contours, and yet offers sufficient stiffness to maintain a space over the bony defect. The micro porous surface is designed to improve flap attachment but prevent tissue and bacteria ingrowth. Cytoflex® Tef-Guard® is for use as a barrier membrane for guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE), the textured version of Cytoflex® Tef-Guard® has superficial macro texture overlapping the micro pore texture on both surfaces. The cellular level micro texture is invisible to the naked eye, but can be seen at high magnifications. The macro texture provides additional grips for flap attachment.
UNICARE BIOMEDICAL INC.
TEX-100
In Commercial Distribution

  • D767C0401051 ()
  • D767C0401010 ()
C04-0101

  • Pliable-polymer dental regeneration membrane, non-bioabsorbable
Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE) thin film, Cytoflex® Tef-Guard® has a surface texture and porosity suitable for adhesion of host cells to the material while blocking passage and integration of bacteria within the interstices of the material. The supple membrane conforms easily to tissue contours, and yet offers sufficient stiffness to maintain a space over the bony defect. The micro porous surface is designed to improve flap attachment but prevent tissue and bacteria ingrowth. Cytoflex® Tef-Guard® is for use as a barrier membrane for guided tissue regeneration procedures. The cellular level micro texture is invisible to the naked eye, but can be seen at high magnifications.
UNICARE BIOMEDICAL INC.
TEF-001
In Commercial Distribution

  • D767C0103051 ()
  • D767C0103010 ()
C01-0301

  • Pliable-polymer dental regeneration membrane, non-bioabsorbable
Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE) thin film, Cytoflex® Tef-Guard® has a surface texture and porosity suitable for adhesion of host cells to the material while blocking passage and integration of bacteria within the interstices of the material. The supple membrane conforms easily to tissue contours, and yet offers sufficient stiffness to maintain a space over the bony defect. The micro porous surface is designed to improve flap attachment but prevent tissue and bacteria ingrowth. Cytoflex® Tef-Guard® is for use as a barrier membrane for guided tissue regeneration procedures. The cellular level micro texture is invisible to the naked eye, but can be seen at high magnifications.
UNICARE BIOMEDICAL INC.
TEF-002
In Commercial Distribution

  • D767C0101051 ()
  • D767C0101010 ()
C01-0101

  • Pliable-polymer dental regeneration membrane, non-bioabsorbable
S/P HIGH PERF VPS PUTTY F/S 300ML BASE/CAT #VP8008
Smarthealth, Inc.
SP697673
In Commercial Distribution

  • D766SP6976732 ()
  • D766SP6976731 ()
SP697673

  • Silicone dental impression material
S/P IMPRESSION MATL VPS MONOPHASE FS 50ML*4 #VP9005
Smarthealth, Inc.
SP693133
In Commercial Distribution

  • D766SP6931332 ()
  • D766SP6931331 ()
  • D766SP6931330 ()
SP693133

  • Silicone dental impression material
S/P IMPRESSION MATL VPS MED BODY FS 50ML*4 #VP9009
Smarthealth, Inc.
SP693132
In Commercial Distribution

  • D766SP6931322 ()
  • D766SP6931321 ()
  • D766SP6931320 ()
SP693132

  • Silicone dental impression material
S/P HIGH PERF VPS PUTTY R/S 300ML BASE/CAT #658-00477
Smarthealth, Inc.
SP693130
In Commercial Distribution

  • D766SP6931302 ()
  • D766SP6931301 ()
SP693130

  • Silicone dental impression material
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