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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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Dental Composite resin
Kulzer GmbH
66014561
Not in Commercial Distribution

  • J014660145610 ()
66014561

  • 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.
0048
In Commercial Distribution

  • D83600480 ()
0048

  • Dental composite resin
• Eagle-Light, Self & Dual-Cure Core Build-Up Material 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 Eagle kit contains two shades: contrasting for easy distinguishing from tooth structure; and the natural for use under semi-transparent ceramics.
DENT ZAR, INC.
0044
In Commercial Distribution

  • D83600441 ()
  • D83600440 ()
0044

  • Dental composite resin
• Eagle-Light, Self & Dual-Cure Core Build-Up Material 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 Eagle kit contains two shades: contrasting for easy distinguishing from tooth structure; and the natural for use under semi-transparent ceramics.
DENT ZAR, INC.
0043
In Commercial Distribution

  • D83600431 ()
  • D83600430 ()
0043

  • Dental composite resin
• Eagle-Light, Self & Dual-Cure Core Build-Up Material 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 Eagle kit contains two shades: contrasting for easy distinguishing from tooth structure; and the natural for use under semi-transparent ceramics.
DENT ZAR, INC.
0042
In Commercial Distribution

  • D83600421 ()
  • D83600440 ()
0042

  • Dental composite resin
GRADIA® Cartridge(1CORE Cartridge 10 mL (20 g), 20 GC Automix Tips for Endo, 20 Extension Tips)
Gc America Inc.
003652
In Commercial Distribution

  • D0470036521 ()
003652

  • Dental composite resin
GRADIA® Cartridge(1CORE Cartridge 10 mL (20 g), 20 GC Automix Tips for Endo, 20 Extension Tips)
Gc America Inc.
003652
In Commercial Distribution

  • 14548161282970 ()
003652

  • Dental composite resin
Self-adhesive dual-cure composite cement. Inseparable. Zirconia and PermaCem 2.0. Content: 1 syringe @ 9 g paste, Accessories. Color: Transparent
DMG Chemisch-Pharmazeutische Fabrik GmbH
213368
In Commercial Distribution

  • EDMG2133681 ()
  • EDMG2133680 ()
213368

  • Dental composite resin
Self-adhesive dual-cure composite cement. Inseparable. Zirconia and PermaCem 2.0. Content: 1 syringe @ 9 g paste, Accessories. Color: A2
DMG Chemisch-Pharmazeutische Fabrik GmbH
213366
In Commercial Distribution

  • EDMG2133661 ()
  • EDMG2133660 ()
213366

  • Dental composite resin
Renamel NANO Compule Start Kit includes 5 Packages of Renamel NANO Compule (20 compules 0.25 g ea./package).
COSMEDENT, INC.
600225
In Commercial Distribution

  • D7796002253 ()
600225

  • Dental composite resin
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