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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CEREC® Essentials Combo Kit with Celtra® Duo (ZLS) Blocks
DENTSPLY INTERNATIONAL INC.
607103
Not in Commercial Distribution

  • D0026071031 ()

  • 4 blocks, 3 Firing Pads, 1 Syringe Coupling Agent, 1 Overglaze, 1 Stain & Glaze Liquid, 1 Calibra Ceram Syringe, 10 mix tips, 1 mixing well, 1 bottle Prime&Bond elect, 25 flocked applicator tips
607103

  • Dental appliance fabrication material, ceramic
Standard Imaging Stereotactic Dose Verification Phantom can be used for a wide variety of tests including routine absolute dosimetry output checks and treatment planning system(TPS) commissioning and quality assurance(QA) tests as recommended by TG 53 and IEC 430 Treatment Planning System Commissioning and QA Standards. Patient specific dosimetry tests can be performed easily as well.
STANDARD IMAGING INC.
91250
In Commercial Distribution

  • 00850019946529 ()
91250

  • Multi-modality therapeutic radiation phantom, test object
Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets. Rely•a•Bond® is a No Mix Bonding System that sets on contact. Kit contains. 14g Adhesive Paste ( tips), 16g Primer, etchant (liquid or gel), mixing pad, spatulas and brushes. This is a No Fluoride Kit in Tips
RELIANCE ORTHODONTIC PRODUCTS INC
RT
In Commercial Distribution

  • D798RT0 ()
RT

  • Orthodontic bracket adhesive
  • Dental etching solution
Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets.Rely•a•Bond® is a No Mix Bonding System that sets on contact. This Rely A Bond Kit Contains 1 X 14g Adhesive Paste in Jar, 1 X 16g Primer with fluoride, 1 X etchant 9g liquid , and mixing accessories. Contains fluoride
RELIANCE ORTHODONTIC PRODUCTS INC
RJF
In Commercial Distribution

  • D798RJF0 ()
RJF

  • Orthodontic bracket adhesive
Whip Mix VeriSplint™ OS is a light-cured resin and sold as Rx only. It is a base polymer used to create removable structures for therapeutic restorations i.e., bite guards/splints and occlusal night guards/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.
WHIP-MIX CORPORATION
71174
In Commercial Distribution

  • D040711740 ()


  • Dental appliance fabrication material, resin
Whip Mix VeriSplint™ OS is a light-cured resin and sold as Rx only. It is a base polymer used to create removable structures for therapeutic restorations i.e., bite guards/splints and occlusal night guards/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.
WHIP-MIX CORPORATION
71147
Not in Commercial Distribution

  • D040711471 ()


  • Dental appliance fabrication material, resin
ANTIBIOTIC OINTMENT ANTISEPTIC TOWELETTE BURN DRESSING CPR MASK ELECTOLYTE DRINK MIX EMERGENCY RESCUE BLANKET EYE PAD FABRIC FINGERTIP BANDAGE FABRIC KNUCKLE BANDAGE FIRST AID / BURN CREAM FIRST AID GUIDE FIRST AID TAPE GAUZE PAD GAUZE ROLL HAND SANITIZER INSTANT ICE PACK NITRILE GLOVES PLASTIC BANDAGE SCISSORS SINGLE USE EYEWASH STING WIPES SUNSCREEN PACKETS TRAUMA PAD TRIANGULAR BANDAGE TWEEZERS
ULINE, INC.
H-11036
In Commercial Distribution

  • 10850015055581 ()


  • First aid kit, medicated
Aquasil® Ultra+ Introductory Kit
DENTSPLY INTERNATIONAL INC.
678695
In Commercial Distribution

  • D0026786951 ()

  • 2 AU+ Heavy FS 50mL cartridges, 1 AU+ LV FS 50mL cartridge, 1 AU+ XLV FS 50mL cartridge, 12 mix tips, 6 intraoral tips, 1 bottle (14mL) Caulk tray adhesive, 1 AU+ digit LV/XLV FS evaulator kit
  • Total Volume: 50 Milliliter
678695

  • Silicone dental impression material
CEREC® Essentials with Celtra® Chairside Consumables Kit
DENTSPLY INTERNATIONAL INC.
61N002
Not in Commercial Distribution

  • D00261N0021 ()

  • 12 Blocks, 3 Firing Pads, 1 Syr. Calibra Ceram w/10 mix tips, 1 bottle Prime&Bond elect, 25 flocked app. tips, 1 disp. well, 1 syr. Coupling Agent w/25 disp. app. needles, 1 Stain & Glaze Kit
61N002

  • Dental appliance fabrication material, ceramic
AH Plus endodontic sealer in tubes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin for an easy manual mix. It functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus endodontic sealer does not stain teeth.
Dentsply De Trey GmbH
60620110NA
In Commercial Distribution

  • D01060620110NA1 ()

  • Total Volume: 8 Milliliter
60620110NA

  • Dental epoxy resin
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