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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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Health-Tec VPS Putty Kit, Regular Set, Mint
Dental Health Products Inc
290-00003
In Commercial Distribution

  • D773290000031 ()
  • D773290000033 ()

  • Total Volume: 600 Milliliter
290-00003

  • Silicone dental impression material
Health-Tec VPS Putty Kit, Fast Set, Unflavored
Dental Health Products Inc
290-00002
In Commercial Distribution

  • D773290000021 ()
  • D773290000023 ()

  • Total Volume: 600 Milliliter
290-00002

  • Silicone dental impression material
Health-Tec VPS Putty Kit, Regular Set, Unflavored
Dental Health Products Inc
290-00001
In Commercial Distribution

  • D773290000011 ()
  • D773290000013 ()

  • Total Volume: 600 Milliliter
290-00001

  • Silicone dental impression material
Health-Tec Bite Registration Material, Super Fast Set, Cool Mint
Dental Health Products Inc
150-203
In Commercial Distribution

  • D7731502031 ()
  • D7731502030 ()
  • D7731502033 ()

  • 50ml
150-203

  • Silicone dental impression material
Health-Tec Bite Registration Material, Fast Set, Cool Mint
Dental Health Products Inc
150-202
In Commercial Distribution

  • D7731502021 ()
  • D7731502020 ()
  • D7731502023 ()

  • 50ml
150-202

  • Silicone dental impression material
Health-Tec Bite Registration Material, Super Fast Set, Unflavored
Dental Health Products Inc
150-103
In Commercial Distribution

  • D7731501031 ()
  • D7731501030 ()
  • D7731501033 ()

  • 50ml
150-103

  • Silicone dental impression material
Health-Tec Bite Registration Material, Fast Set, Unflavored
Dental Health Products Inc
150-102
In Commercial Distribution

  • D7731501021 ()
  • D7731501020 ()
  • D7731501023 ()

  • 50ml
150-102

  • Silicone dental impression material
Health-Tec Bite Registration Material, Regular Set, Unflavored
Dental Health Products Inc
150-101
In Commercial Distribution

  • D7731501011 ()
  • D7731501010 ()
  • D7731501013 ()

  • 50ml
150-101

  • Silicone dental impression material
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
Luer Loc Tips are used to dispense adhesive from a luer lok syringe.
RELIANCE ORTHODONTIC PRODUCTS INC
LLTIPS10
In Commercial Distribution

  • D798LLTIPS102 ()
  • D798LLTIPS101 ()
  • D798LLTIPS100 ()
LLTIPS10

  • Dental material injection cannula, single-use
Gel Etchant is intended for use in the etching of enamel surface prior to bonding. This is a 6.5gm push syringe of gel etchant with 20 tips.
RELIANCE ORTHODONTIC PRODUCTS INC
EGSS
In Commercial Distribution

  • D798EGSS1 ()
  • D798EGSS0 ()
EGSS

  • Dental etching solution
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
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