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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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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
Contains one (1) each of the Lucitone HIPA® Intensive Colors shades - Red, Yellow, White, Brown, and Blue (10 g each)
Dentsply International Inc.
Intensive Color Kit
Not in Commercial Distribution

  • D0019059900 ()
905990

  • Dental appliance fabrication material, resin
3M™ ESPE™ Ketac™ Bond Double Pack, 2 Powder 10 g each, Shade Yellow, 1 Liquid 12 mL, 37390
3M Deutschland GmbH
37390
In Commercial Distribution

  • J001702011101550 ()
37390

  • Glass ionomer dental cement
Water soluble glycerin-free Try-in-paste for Veneer cementation. Veneer cementation with added value. Content: 1 syringe @ 3.9 g Try-in-paste, accessories. Color: Pink.
DMG Chemisch-Pharmazeutische Fabrik GmbH
213055
In Commercial Distribution

  • EDMG2130551 ()
213055

  • Dental composite resin
Automix core build-up composite. Core buildups and post cementation with 5 stars. Content: 1 cartridge @ 50 g paste, Accessories. Color: A3
DMG Chemisch-Pharmazeutische Fabrik GmbH
212033
In Commercial Distribution

  • EDMG2120331 ()
  • EDMG2120330 ()
212033

  • Dental composite resin
Temporary crown and bridge material automix system; bis acrylic composite. Naturally esthetic. Content: 1 syringe @ 15 g paste, accessories. Color: BL.
DMG Chemisch-Pharmazeutische Fabrik GmbH
110723
In Commercial Distribution

  • EDMG1107230 ()
  • EDMG1107231 ()
110723

  • Temporary dental crown/bridge
Dual cure temporary crown and bridge material automix system; bis acrylic composite. Content: 1 cartridge @ 76 g paste, accessories. Color: A2.
DMG Chemisch-Pharmazeutische Fabrik GmbH
110360
In Commercial Distribution

  • EDMG1103608 ()
  • EDMG1103601 ()
  • EDMG1103600 ()
110360

  • Temporary dental crown/bridge
Content: 37 x different ceramics with reduced amount (10 g each), 1 x ICE Build Up Liquid, 1 x glass plate
ZIRKONZAHN SRL
KEAA4151
In Commercial Distribution

  • D800KEAA41510 ()


  • Dental appliance fabrication material, ceramic
Content: 37 x different ceramics with reduced amount (10 g each), 1 x ICE Build Up Liquid, 1 x glass plate
ZIRKONZAHN SRL
KEAA4151
In Commercial Distribution

  • D800KEAA4151 ()


  • Dental appliance fabrication material, ceramic
Content: 6 x tissue coloured ceramics (20 g each) Colour scale from very bright (Tissue 1) to very dark (Tissue 6)
ZIRKONZAHN SRL
KEAA6291
In Commercial Distribution

  • D800KEAA62910 ()


  • Dental appliance fabrication material, ceramic
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