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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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Classic Blu-Mousse® Standard-Cartridge System
PARKELL, INC.
S438
Not in Commercial Distribution

  • M595S4381 ()
  • M595S4380 ()
S438

  • Silicone dental impression material
Peppermint Classic Blu-Mousse® In Split-Cartridge System
PARKELL, INC.
S437S
Not in Commercial Distribution

  • M595S437S1 ()
  • M595S437S0 ()
S437S

  • Silicone dental impression material
Cinch™ Platinum Tubes (Contains: 2-Tubes Base & 2-Tubes Catalyst)
PARKELL, INC.
S435
Not in Commercial Distribution

  • M595S4351 ()
  • M595S4350 ()
S435

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

  • M595S3061 ()
  • M595S3060 ()
S306

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

  • M595S3051 ()
  • M595S3050 ()
S305

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

  • M595S3041 ()
  • M595S3040 ()
S304

  • Dental composite resin
Replacement Reservoir Bottles for Integra™ Scaler (2 Bottles & Caps)
PARKELL, INC.
D681
Not in Commercial Distribution

  • M595D6811 ()
  • M595D6810 ()
D681

  • Ultrasonic dental scaling/debridement system
Universal Ground Clip (Pkg. of 2 pcs.)
PARKELL, INC.
D619GC
Not in Commercial Distribution

  • M595D619GC1 ()
  • M595D619GC0 ()
D619GC

  • Endodontic apex locator
Empty Bottles for PerioSonic Irrigator D583 & D584 (6 Bottles & Caps)
PARKELL, INC.
D581
Not in Commercial Distribution

  • M595D5811 ()
  • M595D5810 ()
D581

  • Ultrasonic dental scaling/debridement system
Aurora™ S3 Tacking Lens D546 (Pkg. of 5 pcs.)
PARKELL, INC.
D548
Not in Commercial Distribution

  • M595D5481 ()
  • M595D5480 ()
D548

  • Dental/surgical polymerization lamp
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