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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SEPTODONT, INC
01C2400
In Commercial Distribution

  • 00303620000963 ()

  • Weight: 3.5 Gram


  • Dental pit/fissure sealant
CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Kit. Italian
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-05 I
In Commercial Distribution

  • D801ID6005I1 ()
60-05

  • Dentine adhesive
CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Enamel Primer Bottle. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-052 I
In Commercial Distribution

  • D801ID60052I1 ()
60-052

  • Dentine adhesive
CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Syringe. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-051 I
In Commercial Distribution

  • D801ID60051I1 ()
60-05

  • Dentine adhesive
DELTON® FS+ FLOWABLE Pit & Fissure Sealant with FLUORIDE Light Curing Opaque. Refill Kit. Also contains: Delton® Syringes, EZ Etch Syringe, EZ Tips, and Syringe Sleeves.
Dentsply Professional
310201
In Commercial Distribution

  • D0033102012 ()
  • D0033102011 ()

  • Weight: 1.9 Gram


  • Cable/lead/sensor/probe cover, non-sterile
  • Dental composite resin
DELTON® FS+ FLOWABLE Pit & Fissure Sealant with FLUORIDE Light Curing Opaque. Also contains: Delton® Syringes, EZ Etch Syringe, EZ Tips, and Syringe Sleeves.
Dentsply Professional
310101
In Commercial Distribution

  • D0033101012 ()
  • D0033101011 ()

  • Weight: 1.9 Gram


  • Cable/lead/sensor/probe cover, non-sterile
  • Dental composite resin
Prime&Bond® NT™ Light Cured Dental Adhesive Unit Dose Package
DENTSPLY INTERNATIONAL INC.
634356
In Commercial Distribution

  • D0026343561 ()
  • D0026343560 ()

  • 80 Unit Doses Prime&Bond® NT™, 4 Unit Dose Holders, 100 Flocked Applicator tips
634356

  • Dentine adhesive
Self Cure Activator Refill
DENTSPLY INTERNATIONAL INC.
634354
In Commercial Distribution

  • D0026343540 ()

  • Total Volume: 4.5 Milliliter
  • One 4.5mL bottle Self Cure Activator
634354

  • Dentine adhesive
Prime&Bond® NT™ Nano-Technology Dental Adhesive Dual Cure Introductory Kit
DENTSPLY INTERNATIONAL INC.
634353
In Commercial Distribution

  • D0026343531 ()

  • Total Volume: 4.5 Milliliter
  • 1 Bottle Adhesive, 1 Bottle Activator, 1 Syringe Tooth Conditioner Gel, 25 Applicator Tips, 1 Brush Handle, 80 Disposable Brush Tips, 1 Dispensing Well
634353

  • Dentine adhesive
Total Etch Adhesive, 2 (4.5ml) Bottle Refill Package
DENTSPLY INTERNATIONAL INC.
634352
In Commercial Distribution

  • D00263435262 ()
  • D0026343521 ()
  • D0026343520 ()

  • Total Volume: 4.5 Milliliter
  • 2 Bottles Total Etch Adhesive (4.5mL)
634352

  • Dentine adhesive
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