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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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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
S/P IMPRESSION MATL VPS MONOPHASE 50ML *4 658-00476
Smarthealth, Inc.
SP693129
In Commercial Distribution

  • D766SP6931292 ()
  • D766SP6931291 ()
  • D766SP6931290 ()
SP693129

  • Silicone dental impression material
S/P IMPRESSION MATL VPS MED BODY 50ML*4 658-00474
Smarthealth, Inc.
SP693128
In Commercial Distribution

  • D766SP6931282 ()
  • D766SP6931281 ()
  • D766SP6931280 ()
SP693128

  • Silicone dental impression material
S/P IMPRESSION MATL VPS LT BODY R/S 50ML CART*4 658-00472
Smarthealth, Inc.
SP693127
In Commercial Distribution

  • D766SP6931272 ()
  • D766SP6931271 ()
  • D766SP6931270 ()
SP693127

  • Silicone dental impression material
S/P IMPRESSION MATL VPS LT BODY F/S 50ML CART*4 #VP8003S
Smarthealth, Inc.
SP693126
In Commercial Distribution

  • D766SP6931262 ()
  • D766SP6931261 ()
  • D766SP6931260 ()
SP693126

  • Silicone dental impression material
S/P IMPRESSION MATL VPS HVY BODY REG 50ML*4 658-00475 #VP8007
Smarthealth, Inc.
SP693125
In Commercial Distribution

  • D766SP6931252 ()
  • D766SP6931251 ()
  • D766SP6931250 ()
SP693125

  • Silicone dental impression material
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