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 Class Implantable

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DELTAGLACE, Bottle 10ml
DeltaMed GmbH
1370030
In Commercial Distribution

  • EDEL13700300 ()
1370030

  • Dental occlusal splint, custom-made
DELTABOND, Bottle 10ml
DeltaMed GmbH
1370020
In Commercial Distribution

  • EDEL13700200 ()
1370020

  • Dental prosthesis priming agent
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
The POD
SELANE PRODUCTS, INC.
62065
In Commercial Distribution

  • D854620651 ()


  • Custom-made mouthguard
Ceramill Splintec 98x20 N/US
Merz Dental GmbH
Ceramill Splintec 98x20 N/US
In Commercial Distribution

  • D709760533 ()

  • Height: 20 Millimeter
  • Outer Diameter: 98 Millimeter
760533

  • Dental occlusal splint, custom-made
Ceramill Splintec 98x14 N/US
Merz Dental GmbH
Ceramill Splintec 98x14 N/US
In Commercial Distribution

  • D709760532 ()

  • Height: 14 Millimeter
  • Outer Diameter: 98 Millimeter
760532

  • Dental occlusal splint, custom-made
Ceramill Splintec 71 L US 20mm
Merz Dental GmbH
Ceramill Splintec 71 L US 20mm
In Commercial Distribution

  • D709760319 ()

  • Height: 20 Millimeter
  • Outer Diameter: 71 Millimeter
760319

  • Dental occlusal splint, custom-made
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