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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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VIRT UNIV B1 10pc BAGGED
DEN-MAT HOLDINGS, LLC
030381966
In Commercial Distribution

  • D8130303819661 ()
  • D8130303819660 ()
030381966

  • Dental composite resin
VIRT UNIV C1 10pc BAGGED
DEN-MAT HOLDINGS, LLC
030381965
In Commercial Distribution

  • D8130303819651 ()
  • D8130303819650 ()
030381965

  • Dental composite resin
VIRT UNIV C2 10pc BAGGED
DEN-MAT HOLDINGS, LLC
030381964
In Commercial Distribution

  • D8130303819641 ()
  • D8130303819640 ()
030381964

  • Dental composite resin
VIRT UNIV A2 10pc BAGGED
DEN-MAT HOLDINGS, LLC
030381963
In Commercial Distribution

  • D8130303819631 ()
  • D8130303819630 ()
030381963

  • Dental composite resin
VIRT UNIV ENM TRNS 10pc BAGGED
DEN-MAT HOLDINGS, LLC
030381962
In Commercial Distribution

  • D8130303819621 ()
  • D8130303819620 ()
030381962

  • Dental composite resin
VIRT UNIV A3.5 10pc BAGGED
DEN-MAT HOLDINGS, LLC
030381961
In Commercial Distribution

  • D8130303819611 ()
  • D8130323818350 ()
030381961

  • Dental composite resin
Saturn M-Light, Self & Dual-Cure Core Build-Up Material (1:4 Formula) • in dual cure mode restorative pastes are mixed with accelerators, this permits complete set of the material irrespective of the thickness of the restoration, or the accessibility of light. • Virtually unlimited working time in light-cure mode; convenient working time in self-cure mode. • Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts. • Moldable, non sticky consistency. • Allows one to control consistency, whenever desirable, by adding either liquid or paste-type catalyst for dual cure. • Contains moderately hard filler for easier carving and shaping. • Does not require refrigeration: long shelf life at ambient temperatures. • The Standard Saturn M kit contains two shades: contrasting for easy distinguishing from tooth structure; and the natural for use under semi-transparent ceramics.
DENT ZAR, INC.
0047
In Commercial Distribution

  • D83600471 ()
  • D83600470 ()
0047

  • Dental composite resin
Saturn M-Light, Self & Dual-Cure Core Build-Up Material (1:4 Formula) • in dual cure mode restorative pastes are mixed with accelerators, this permits complete set of the material irrespective of the thickness of the restoration, or the accessibility of light. • Virtually unlimited working time in light-cure mode; convenient working time in self-cure mode. • Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts. • Moldable, non sticky consistency. • Allows one to control consistency, whenever desirable, by adding either liquid or paste-type catalyst for dual cure. • Contains moderately hard filler for easier carving and shaping. • Does not require refrigeration: long shelf life at ambient temperatures. • The Standard Saturn M kit contains two shades: contrasting for easy distinguishing from tooth structure; and the natural for use under semi-transparent ceramics.
DENT ZAR, INC.
0046
In Commercial Distribution

  • D83600461 ()
  • D83600460 ()
0046

  • Dental composite resin
Eagle-Dual-Cure Core Build-Up Material Auto-Mix System • Convenient working time in self-cure mode. • Light-cure properties of the material facilitate cure of the product. • Well balanced x-ray opacity permits tooth structure, pins, and posts to be easily distinguishable from material. • Does not require refrigeration; long shelf-life at ambient temperatures. • Significantly saves chair-time due to its auto-mix system. • Intra-oral tips permit application of the material directly into the tooth.
DENT ZAR, INC.
1020
In Commercial Distribution

  • D83610201 ()
  • D83610200 ()
1020

  • Dental composite resin
Orion is a light-cure core build-up material. It has, virtually, unlimited working time. Material is easy to carve and contour, due to it, moderately hard filler. It is moldable, non-sticky yet adhesive consistency. Material has long shelf life at ambient temperatures and its X-ray opaque.
DENT ZAR, INC.
1019
In Commercial Distribution

  • D83610191 ()
  • D83610190 ()
1019

  • Dental composite resin
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