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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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audioprint INR-1 - EPRCA1000205

audioprint INR-1 Generative resin for production of earpieces
pro3dure medical GmbH
500 g bottle ; amber
In Commercial Distribution

  • EPRCA1000205 ()
A1000205

  • Earmould, custom-made

audioprint INR-1 - EPRCA1000204

audioprint INR-1 Generative resin for production of earpieces
pro3dure medical GmbH
500 g bottle ; blue-transparent
In Commercial Distribution

  • EPRCA1000204 ()
A1000204

  • Earmould, custom-made

audioprint INR-1 - EPRCA1000202

audioprint INR-1 Generative resin for production of earpieces
pro3dure medical GmbH
500 g bottle ; red-transparent
In Commercial Distribution

  • EPRCA1000202 ()
A1000202

  • Earmould, custom-made

VENUS FLOW SYR ASSORTMENT 4 x 1,8 G - J014660145610

Dental Composite resin
Kulzer GmbH
66014561
Not in Commercial Distribution

  • J014660145610 ()
66014561

  • Dental composite resin

Saturn M Rest Liquid Additive (Bottle 6 g) - D83600480

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 Part A Cont. (Two 4.5 g Syringes) - D83600441

• 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 Part A Nat (Two 4.5 g Syringes) - D83600431

• 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 Part B Paste. (Two 4.5 g Syringes) - D83600421

• 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

luxaprint 3D shell UV intensive red 1000 g - EDET036011

No Description
DETAX GmbH
03601
In Commercial Distribution

  • EDET036011 ()


  • Earmould, custom-made

luxaprint 3D shell UV intensive blue 1000 g - EDET035911

No Description
DETAX GmbH
03591
In Commercial Distribution

  • EDET035911 ()


  • Earmould, custom-made
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