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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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LuxaCore® Z Dual - EDMG2133360

Core build-up composite with zirconium oxide and nano technology. Feels like natural dentine for precise preparation. Content: 2 syringes @ 9 g paste, Accessories. Color: Light opaque
DMG Chemisch-Pharmazeutische Fabrik GmbH
213336
In Commercial Distribution

  • EDMG2133368 ()
  • EDMG2133361 ()
  • EDMG2133360 ()
213336

  • Dental composite resin

LuxaCore® Z Dual - EDMG2133350

Core build-up composite with zirconium oxide and nano technology. Feels like natural dentine for precise preparation. Content: 2 syringes @ 9 g paste, Accessories. Color: Blue
DMG Chemisch-Pharmazeutische Fabrik GmbH
213335
In Commercial Distribution

  • EDMG2133358 ()
  • EDMG2133351 ()
  • EDMG2133350 ()
213335

  • Dental composite resin

LuxaCore® Z Dual - EDMG2133340

Core build-up composite with zirconium oxide and nano technology. Feels like natural dentine for precise preparation. Content: 2 syringes @ 9 g paste, Accessories. Color: A3
DMG Chemisch-Pharmazeutische Fabrik GmbH
213334
In Commercial Distribution

  • EDMG2133348 ()
  • EDMG2133341 ()
  • EDMG2133340 ()
213334

  • Dental composite resin

LuxaCore® Z Dual - EDMG2133320

Core build-up composite with zirconium oxide and nano technology. Feels like natural dentine for precise preparation. Content: 1 cartridge @ 48 g paste, Accessories. Color: Light opaque
DMG Chemisch-Pharmazeutische Fabrik GmbH
213332
In Commercial Distribution

  • EDMG2133328 ()
  • EDMG2133321 ()
  • EDMG2133320 ()
213332

  • Dental composite resin

LuxaCore® Z Dual - EDMG2133310

Core build-up composite with zirconium oxide and nano technology. Feels like natural dentine for precise preparation. Content: 1 cartridge @ 48 g paste, Accessories. Color: Blue
DMG Chemisch-Pharmazeutische Fabrik GmbH
213331
In Commercial Distribution

  • EDMG2133318 ()
  • EDMG2133311 ()
  • EDMG2133310 ()
213331

  • Dental composite resin

LuxaCore® Z Dual - EDMG2133300

Core build-up composite with zirconium oxide and nano technology. Feels like natural dentine for precise preparation. Content: 1 cartridge @ 48 g paste, Accessories. Color: A3
DMG Chemisch-Pharmazeutische Fabrik GmbH
213330
In Commercial Distribution

  • EDMG2133308 ()
  • EDMG2133301 ()
  • EDMG2133300 ()
213330

  • Dental composite resin

LuxaCore® Automix Dual - EDMG2121260

Core build-up composite. Core buildups and post cementation with 5 stars. Content: 1 cartridge 50 ml paste, Accessories
DMG Chemisch-Pharmazeutische Fabrik GmbH
212126
In Commercial Distribution

  • EDMG2121268 ()
  • EDMG2121261 ()
  • EDMG2121260 ()
212126

  • Dental composite resin

LuxaCore® Smartmix Dual - EDMG2120640

Core build-up composite. Core buildups and post cementation with 5 stars. Content: 2 syringes @ 9 g paste, Accessories. Color: White
DMG Chemisch-Pharmazeutische Fabrik GmbH
212064
In Commercial Distribution

  • EDMG2120648 ()
  • EDMG2120641 ()
  • EDMG2120640 ()
212064

  • Dental composite resin

LuxaCore® Smartmix Dual - EDMG2120390

Core build-up composite. Core buildups and post cementation with 5 stars. Content: 2 syringes @ 9 g paste, Accessories. Color: A3
DMG Chemisch-Pharmazeutische Fabrik GmbH
212039
In Commercial Distribution

  • EDMG2120398 ()
  • EDMG2120391 ()
  • EDMG2120390 ()
212039

  • Dental composite resin

LuxaCore® Smartmix Dual - EDMG2120380

Core build-up composite. Core buildups and post cementation with 5 stars. Content: 2 syringes @ 9 g paste, Accessories. Color: Blue
DMG Chemisch-Pharmazeutische Fabrik GmbH
212038
In Commercial Distribution

  • EDMG2120388 ()
  • EDMG2120381 ()
  • EDMG2120380 ()
212038

  • Dental composite resin

LuxaCore® Automix Dual - EDMG2120120

Core build-up composite. Core buildups and post cementation with 5 stars. Content: 1 cartridge @ 50 ml paste, Accessories. Color: Blue
DMG Chemisch-Pharmazeutische Fabrik GmbH
212012
In Commercial Distribution

  • EDMG2120128 ()
  • EDMG2120121 ()
  • EDMG2120120 ()
212012

  • Dental composite resin

LuxaCore® Automix Dual - EDMG2120110

Core build-up composite. Core buildups and post cementation with 5 stars. Content: 1 cartridge @ 50 ml paste, accessories. Color: A3.
DMG Chemisch-Pharmazeutische Fabrik GmbH
212011
In Commercial Distribution

  • EDMG2120118 ()
  • EDMG2120111 ()
  • EDMG2120110 ()
212011

  • Dental composite resin

Absolute Dentin™ - M595S3060

10ml. Blue Absolute Dentin™ (2 Cartridges; 20ml. Total)
PARKELL, INC.
S306
Not in Commercial Distribution

  • M595S3061 ()
  • M595S3060 ()
S306

  • Dental composite resin

Absolute Dentin™ - M595S3050

10ml. Tooth Shade Absolute Dentin™ (2 Cartridges; 20ml. Total)
PARKELL, INC.
S305
Not in Commercial Distribution

  • M595S3051 ()
  • M595S3050 ()
S305

  • Dental composite resin

Absolute Dentin™ - M595S3040

10ml. Artic White Absolute Dentin™ (2 Cartridges; 20ml. Total)
PARKELL, INC.
S304
Not in Commercial Distribution

  • M595S3041 ()
  • M595S3040 ()
S304

  • Dental composite resin

Tetric Prime - DVIV706622WW1

Tetric Prime Refill 1x3g Bleach L
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
706622WW
In Commercial Distribution

  • DVIV706622WW2 ()
  • DVIV706622WW1 ()
706622WW

  • Dental composite resin

Tetric Prime - DVIV706621WW1

Tetric Prime Refill 1x3g T
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
706621WW
In Commercial Distribution

  • DVIV706621WW2 ()
  • DVIV706621WW1 ()
706621WW

  • Dental composite resin

Tetric Prime - DVIV706619WW1

Tetric Prime Refill 1x3g A3.5 Dentin
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
706619WW
In Commercial Distribution

  • DVIV706619WW2 ()
  • DVIV706619WW1 ()
706619WW

  • Dental composite resin

Tetric Prime - DVIV706618WW1

Tetric Prime Refill 1x3g A2 Dentin
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
706618WW
In Commercial Distribution

  • DVIV706618WW2 ()
  • DVIV706618WW1 ()
706618WW

  • Dental composite resin

Tetric Prime - DVIV706615WW1

Tetric Prime Refill 1x3g C2
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
706615WW
In Commercial Distribution

  • DVIV706615WW2 ()
  • DVIV706615WW1 ()
706615WW

  • Dental composite resin

Tetric Prime - DVIV706615US1

Tetric Prime Refill 1x3g C2
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
706615US
Not in Commercial Distribution

  • DVIV706615US2 ()
  • DVIV706615US1 ()
706615US

  • Dental composite resin

Tetric Prime - DVIV706613WW1

Tetric Prime Refill 1x3g B2
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
706613WW
In Commercial Distribution

  • DVIV706613WW2 ()
  • DVIV706613WW1 ()
706613WW

  • Dental composite resin

Tetric Prime - DVIV706612WW1

Tetric Prime Refill 1x3g B1
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
706612WW
In Commercial Distribution

  • DVIV706612WW2 ()
  • DVIV706612WW1 ()
706612WW

  • Dental composite resin

Tetric Prime - DVIV706611WW1

Tetric Prime Refill 1x3g A4
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
706611WW
In Commercial Distribution

  • DVIV706611WW2 ()
  • DVIV706611WW1 ()
706611WW

  • Dental composite resin

Tetric Prime - DVIV706610WW1

Tetric Prime Refill 1x3g A3.5
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
706610WW
In Commercial Distribution

  • DVIV706610WW2 ()
  • DVIV706610WW1 ()
706610WW

  • Dental composite resin

Tetric Prime - DVIV706609WW1

Tetric Prime Refill 1x3g A3
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
706609WW
In Commercial Distribution

  • DVIV706609WW2 ()
  • DVIV706609WW1 ()
706609WW

  • Dental composite resin

Tetric Prime - DVIV706608WW1

Tetric Prime Refill 1x3g A2
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
706608WW
In Commercial Distribution

  • DVIV706608WW2 ()
  • DVIV706608WW1 ()
706608WW

  • Dental composite resin

Tetric Prime - DVIV706607WW1

Tetric Prime Refill 1x3g A1
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
706607WW
In Commercial Distribution

  • DVIV706607WW2 ()
  • DVIV706607WW1 ()
706607WW

  • Dental composite resin

Tetric - DVIV612467AN1

Tetric Refill 3x3g Basic White
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612467AN
Not in Commercial Distribution

  • DVIV612467AN1 ()
  • DVIV612467AN0 ()
  • DVIV612467AN2 ()
612467AN

  • Dental composite resin

Tetric - DVIV612464AN1

Tetric Refill 20x0.2g T
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612464AN
Not in Commercial Distribution

  • DVIV612464AN1 ()
  • DVIV612464AN0 ()
  • DVIV612464AN2 ()
612464AN

  • Dental composite resin

Tetric - DVIV612463AN1

Tetric Refill 20x0.2g A3.5 Dentin
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612463AN
Not in Commercial Distribution

  • DVIV612463AN1 ()
  • DVIV612463AN0 ()
  • DVIV612463AN2 ()
612463AN

  • Dental composite resin

Tetric - DVIV612462AN1

Tetric Refill 20x0.2g B2
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612462AN
Not in Commercial Distribution

  • DVIV612462AN1 ()
  • DVIV612462AN0 ()
  • DVIV612462AN2 ()
612462AN

  • Dental composite resin

Tetric - DVIV612461AN1

Tetric Refill 20x0.2g B3
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612461AN
Not in Commercial Distribution

  • DVIV612461AN1 ()
  • DVIV612461AN0 ()
  • DVIV612461AN2 ()
612461AN

  • Dental composite resin

Tetric - DVIV612460AN1

Tetric Refill 20x0.2g A4
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612460AN
Not in Commercial Distribution

  • DVIV612460AN1 ()
  • DVIV612460AN0 ()
  • DVIV612460AN2 ()
612460AN

  • Dental composite resin

Tetric - DVIV612459AN1

Tetric Refill 20x0.2g A3.5
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612459AN
Not in Commercial Distribution

  • DVIV612459AN1 ()
  • DVIV612459AN0 ()
  • DVIV612459AN2 ()
612459AN

  • Dental composite resin

Tetric - DVIV612458AN1

Tetric Refill 20x0.2g A3
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612458AN
Not in Commercial Distribution

  • DVIV612458AN1 ()
  • DVIV612458AN0 ()
  • DVIV612458AN2 ()
612458AN

  • Dental composite resin

Tetric - DVIV612457AN1

Tetric Refill 20x0.2g A2
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612457AN
Not in Commercial Distribution

  • DVIV612457AN1 ()
  • DVIV612457AN0 ()
  • DVIV612457AN2 ()
612457AN

  • Dental composite resin

Tetric - DVIV612456AN1

Tetric Refill 20x0.2g A1
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612456AN
Not in Commercial Distribution

  • DVIV612456AN1 ()
  • DVIV612456AN0 ()
  • DVIV612456AN2 ()
612456AN

  • Dental composite resin

Tetric - DVIV612454AN1

Tetric Refill 1x3g T
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612454AN
Not in Commercial Distribution

  • DVIV612454AN1 ()
  • DVIV612454AN2 ()
612454AN

  • Dental composite resin

Tetric - DVIV612453AN1

Tetric Refill 1x3g A3.5 Dentin
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612453AN
Not in Commercial Distribution

  • DVIV612453AN1 ()
  • DVIV612453AN2 ()
612453AN

  • Dental composite resin

Tetric - DVIV612452AN1

Tetric Refill 1x3g B2
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612452AN
Not in Commercial Distribution

  • DVIV612452AN1 ()
  • DVIV612452AN2 ()
612452AN

  • Dental composite resin

Tetric - DVIV612451AN1

Tetric Refill 1x3g B3
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612451AN
Not in Commercial Distribution

  • DVIV612451AN1 ()
  • DVIV612451AN2 ()
612451AN

  • Dental composite resin

Tetric - DVIV612450AN1

Tetric Refill 1x3g A4
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612450AN
Not in Commercial Distribution

  • DVIV612450AN1 ()
  • DVIV612450AN2 ()
612450AN

  • Dental composite resin

Tetric - DVIV612449AN1

Tetric Refill 1x3g A3.5
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612449AN
Not in Commercial Distribution

  • DVIV612449AN1 ()
  • DVIV612449AN2 ()
612449AN

  • Dental composite resin

Tetric - DVIV612448AN1

Tetric Refill 1x3g A3
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612448AN
Not in Commercial Distribution

  • DVIV612448AN1 ()
  • DVIV612448AN2 ()
612448AN

  • Dental composite resin

Tetric - DVIV612447AN1

Tetric Refill 1x3g A2
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612447AN
Not in Commercial Distribution

  • DVIV612447AN1 ()
  • DVIV612447AN2 ()
612447AN

  • Dental composite resin

Tetric - DVIV612446AN1

Tetric Refill 1x3g A1
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612446AN
Not in Commercial Distribution

  • DVIV612446AN1 ()
  • DVIV612446AN2 ()
612446AN

  • Dental composite resin

Tetric - DVIV612445AN1

Tetric Refill 60x0.2g Basic White
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
612445AN
Not in Commercial Distribution

  • DVIV612445AN1 ()
  • DVIV612445AN0 ()
  • DVIV612445AN2 ()
612445AN

  • Dental composite resin

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
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