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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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Caulk® 34% Tooth Conditioner Gel Phosphoric Acid Gel - D0026461261

Disposable Applicator Tips for Caulk® 34% Tooth Conditioner Gel Syringe - Refill Package
DENTSPLY INTERNATIONAL INC.
646126
In Commercial Distribution

  • D00264612662 ()
  • D0026461261 ()
  • D0026461260 ()

  • 25 Disposable Applicator Tips
646126

  • Dental etching solution

Caulk® 34% Tooth Conditioner Gel Phosphoric Acid Gel - D0026461251

Caulk® 34% Tooth Conditioner Gel Syringe Refill
DENTSPLY INTERNATIONAL INC.
646125
In Commercial Distribution

  • D00264612562 ()
  • D0026461251 ()
  • D0026461250 ()

  • Total Volume: 3 Milliliter
  • 2 Syringes Caulk® Tooth Conditioner Gel (3mL each) and 25 Applicator Tips
646125

  • Dental etching solution

Inman Digital Clear Aligner - D141DCA253720

Inman Digital Clear Aligner
Inman Orthodontic Laboratories, Inc.
DCA253272
In Commercial Distribution

  • D141DCA2532729 ()
  • D141DCA253720 ()


  • Orthodontic progressive aligner

Quala - D23Q4001217

Quala Etch Gel Econo Kit 12-1.2ML Gel 50 Tips
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Q40012
Not in Commercial Distribution

  • D23Q4001217 ()
  • D023Q4001239 ()
Q40012

  • Dental etching solution

Bite Buddy - D8161447000

A thermoplastic material designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device.
ALL DENTAL PRODX
144700
In Commercial Distribution

  • D8161447001 ()
  • D8161447000 ()


  • Composite dental impression material

Zenith Implant Screw Mask - D820ZEN0

Dental Implant Screw Mask
DENALI CORPORATION
ZEN1
In Commercial Distribution

  • D820ZEN1 ()
  • D820ZEN0 ()
ZEN

  • Dental composite resin

Super Liner - D820SLINER0

Cavity Liner, Dental.
DENALI CORPORATION
Single Syringe - White
In Commercial Distribution

  • D820SLINER0 ()
  • D820SLINER1 ()


  • Dental composite resin

Resolve Cleansing Gel - D820RCG0

Cavity Varnish, Dental.
DENALI CORPORATION
Single - Pink
In Commercial Distribution

  • D820RCG0 ()
  • D820RCG1 ()
RCG

  • Dental cavity varnish

HIRO Light Cure Pattern, Modeling and Indexing Resin - D820HIRO0

Light Cure Pattern, Modeling and Indexing Resin.
DENALI CORPORATION
One 3 mL Syringe
Not in Commercial Distribution

  • D820HIRO0 ()
  • D820HIRO1 ()
HIRO

  • Dental prosthesis restorative material, unfilled resin

Bonita Pit and Fissure Sealant - D820BONOW0

Pit and Fissure Sealant, Dental.
DENALI CORPORATION
1.2 mL Opaque White
In Commercial Distribution

  • D820BONOW1 ()
  • D820BONOW0 ()
BONOW

  • Dental pit/fissure sealant
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