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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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No Description
DETAX GmbH
03354
In Commercial Distribution

  • EDET033541 ()


  • Earmould impression material
No Description
DETAX GmbH
03350
In Commercial Distribution

  • EDET033501 ()


  • Earmould impression material
No Description
DETAX GmbH
03349
In Commercial Distribution

  • EDET033491 ()


  • Earmould impression material
No Description
DETAX GmbH
03205
In Commercial Distribution

  • EDET032051 ()


  • Earmould impression material
No Description
DETAX GmbH
02423
In Commercial Distribution

  • EDET024231 ()


  • Earmould impression material
The KKT-M2 device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that qualifies the misalignment between vertebrae. The treatment is then administered using the KKT-M2 device to deliver precise impulses at a required vector configuration.
Optima Health Solutions International Corporation
KKT-M2
In Commercial Distribution

  • B854M20 ()
M2

  • Physical therapy ultrasound system
DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of bite splints (clear variant) or denture bases (gingiva-colored variants) on dental CAD/CAM systems. DD Bio Splint P HI are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints and bite regulators for long-term application in the oral cavity up to 12 months.
Dental Direkt GmbH
98H30
In Commercial Distribution

  • EDDIK401301 ()

  • Height: 30 Millimeter
  • Outer Diameter: 98.5 Millimeter
K40130

  • Dental appliance fabrication material, thermoplastic
DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of bite splints (clear variant) or denture bases (gingiva-colored variants) on dental CAD/CAM systems. DD Bio Splint P HI are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints and bite regulators for long-term application in the oral cavity up to 12 months.
Dental Direkt GmbH
98H25
In Commercial Distribution

  • EDDIK401251 ()

  • Height: 25 Millimeter
  • Outer Diameter: 98.5 Millimeter
K40125

  • Dental appliance fabrication material, thermoplastic
DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of bite splints (clear variant) or denture bases (gingiva-colored variants) on dental CAD/CAM systems. DD Bio Splint P HI are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints and bite regulators for long-term application in the oral cavity up to 12 months.
Dental Direkt GmbH
98H20
In Commercial Distribution

  • EDDIK401201 ()

  • Height: 20 Millimeter
  • Outer Diameter: 98.5 Millimeter
K40120

  • Dental appliance fabrication material, thermoplastic
DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of bite splints (clear variant) or denture bases (gingiva-colored variants) on dental CAD/CAM systems. DD Bio Splint P HI are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints and bite regulators for long-term application in the oral cavity up to 12 months.
Dental Direkt GmbH
98H15
In Commercial Distribution

  • EDDIK401151 ()

  • Height: 15 Millimeter
  • Outer Diameter: 98.5 Millimeter
K40115

  • Dental appliance fabrication material, thermoplastic
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