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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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Blue Gel Etchant is intended for use in etching the tooth surface. Product has high visibility blue color. Product contains BAC (Benzalchromium chloride). 5 gm syringe with 10 tips
RELIANCE ORTHODONTIC PRODUCTS INC
BEGS
In Commercial Distribution

  • D798BEGS1 ()
  • D798BEGS0 ()
BEGS

  • Dental etching solution
Bend A Brushes are intended for use in the application of dental resins, sealants and etchants to the tooth surface.
RELIANCE ORTHODONTIC PRODUCTS INC
BB50
In Commercial Distribution

  • D798BB502 ()
  • D798BB501 ()
  • D798BB500 ()
BB50

  • Dental material application tool, single-use
Plastic, sterilization-safe mixing tool for orthodontic adhesives
RELIANCE ORTHODONTIC PRODUCTS INC
1SPATULA
In Commercial Distribution

  • D7981STAPULA1 ()
  • D7981SPATULA0 ()
1SPATULA

  • Dental material injection cannula, single-use
19 Gauge Tips for use with compatible syringes.
RELIANCE ORTHODONTIC PRODUCTS INC
19TIPS10
In Commercial Distribution

  • D79819TIPS101 ()
  • D79819TIPS100 ()
  • D79819TIPS102 ()
19TIPS10

  • Dental material injection cannula, single-use
Alginate Substitute Fast Set 50ml. Cartridges 8/pk. - MARK3
CARGUS INTERNATIONAL, INC
9010
In Commercial Distribution

  • D79690101 ()
  • D79690100 ()
  • D79690102 ()


  • Silicone dental impression material
Mixing Pad 3" x 3" 50 Sheets - MARK3®*
CARGUS INTERNATIONAL, INC
8584
In Commercial Distribution

  • D79685841 ()
  • D79685842 ()
8584

  • Dental material mixing surface, chairside, single-use
Mixing Pad 2" x 2" 50 Sheets - MARK3®*
CARGUS INTERNATIONAL, INC
8582
In Commercial Distribution

  • D79685821 ()
  • D79685822 ()
8582

  • Dental material mixing surface, chairside, single-use
Assure Plus resin is intended to increase adhesion to normal, atypical (wet or dry) enamel surfaces including: hypocalcified, fluorosed, deciduous enamel and dentin. It will bond to roughened metal (amalgam, gold or stainless steel), porcelain, zirconia, composite restorations, acrylic temporary/pontic teeth. This is a Unidose dispensing system. Single unidose capsule
RELIANCE ORTHODONTIC PRODUCTS INC
UAPSAM
In Commercial Distribution

  • D798UAPSAM1 ()
  • D798UAPSAM0 ()
UAPSAM

  • Dentine bonding agent/set
Assure Plus resin is intended to increase adhesion to normal, atypical (wet or dry) enamel surfaces including: hypocalcified, fluorosed, deciduous enamel and dentin. It will bond to roughened metal (amalgam, gold or stainless steel), porcelain, zirconia, composite restorations, acrylic temporary/pontic teeth. This is a Unidose dispensing system.
RELIANCE ORTHODONTIC PRODUCTS INC
UAP50
Not in Commercial Distribution

  • D798UAP501 ()
  • D798UAP500 ()
  • D798UAP502 ()
UAP50

  • Dentine bonding agent/set
Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets. Rely•a•Bond® is a No Mix Bonding System that sets on contact. This is the Rely A Bond 14g Adhesive paste in Tips.
RELIANCE ORTHODONTIC PRODUCTS INC
RPT
In Commercial Distribution

  • D798RPT1 ()
  • D798RPT0 ()
  • D798RPT2 ()
RPT

  • Orthodontic bracket adhesive
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