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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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DNT BASE REPR PINK SC 1 LB
GARRECO, LLC
3018001
In Commercial Distribution

  • D79330180011 ()
  • D79330180010 ()
3018001

  • Dental appliance fabrication material, resin
DNT BASE REPR PURPLE FIBER SC 1 LB
GARRECO, LLC
3013401
In Commercial Distribution

  • D79330134011 ()
  • D79330134010 ()
3013401

  • Dental appliance fabrication material, resin
DNT BASE REPR LT CHAR SC 1 LB
GARRECO, LLC
3010401
In Commercial Distribution

  • D79330104011 ()
  • D79330104010 ()
3010401

  • Dental appliance fabrication material, resin
DNT BASE REPR DK FIBER SC 5 LBS
GARRECO, LLC
3010305
In Commercial Distribution

  • D79330103051 ()
  • D79330103050 ()
3010305

  • Dental appliance fabrication material, resin
DNT BASE REPR CLEAR SC 5 LBS
GARRECO, LLC
3010105
In Commercial Distribution

  • D79330101051 ()
  • D79330101050 ()
3010105

  • Dental appliance fabrication material, resin
Multiple sensors in an extremely light weight (four ounce) spectacle-like array, track the motion of a tiny magnet attached to the lower incisal gingiva with adhesive material. The configuration is totally non-invasive and, unlike clutches, does not interfere with patient function. The opposing sensors are wide apart permitting unobstructed access to the oral cavity for taking bite registrations and other clinical procedures, and the system is virtually immune from effects of slight head motion or nearby metallic or electronic interference. A patient education mode is included to simplify patient understanding and staff training.
MYOTRONICS NOROMED, INC
K7/CMS
In Commercial Distribution

  • D79209940 ()
  • D79209780 ()


  • Jaw physiology evaluation system
Self Seal 3-1/4" x 12"(3-1/4" x 11") Sterilization Pouches 200/bx. Case 10/cs. - MARK3®
CARGUS INTERNATIONAL, INC
6115
In Commercial Distribution

  • D7966115 ()
  • D79661151 ()
  • D79661152 ()


  • Sterilization container liner
Core Build Up A3 Automix Syringe 5ml. 2/bx. + 10 Mixing Tips & Intra-Oral Tips - MARK3®
CARGUS INTERNATIONAL, INC
5353
In Commercial Distribution

  • D79653530 ()
  • D79653531 ()
  • D79653532 ()
5353

  • Dental composite resin
Chroma Chameleon One Shade Composite 4gm. Syringe - MARK3
CARGUS INTERNATIONAL, INC
4852
In Commercial Distribution

  • D79648522 ()
  • D79648521 ()
4852

  • Dental composite resin
Temporary Cement NE Automix Syringe 5ml. 2/bx. + 20 Mixing Tips - MARK3®
CARGUS INTERNATIONAL, INC
4125
In Commercial Distribution

  • D79641250 ()
  • D79641251 ()
  • D79641252 ()
4125

  • Zinc oxide eugenol dental cement
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