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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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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
Aurora™ S3 Curing Lens D546 (Pkg. of 10 pcs.)
PARKELL, INC.
D547
Not in Commercial Distribution

  • M595D5471 ()
  • M595D5470 ()
D547

  • Dental/surgical polymerization lamp
Tacking Lens for Aurora™ D540 (Pkg. of 5 pcs.)
PARKELL, INC.
D543
Not in Commercial Distribution

  • M595D5431 ()
  • M595D5430 ()
D543

  • Dental/surgical polymerization lamp
Curing Lens for Aurora™ D540 (Pkg. of 10 pcs.)
PARKELL, INC.
D541
Not in Commercial Distribution

  • M595D5411 ()
  • M595D5410 ()
D541

  • Dental/surgical polymerization lamp
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