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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Triceram® Dentin CC 4+1, 40g / dental ceramic material
DENTAURUM GmbH & Co.KG
294-294-60
In Commercial Distribution

  • J011294294600 ()


  • Dental appliance fabrication material, ceramic
Triceram® Dentin CC 3+2, 40g / dental ceramic material
DENTAURUM GmbH & Co.KG
294-288-60
In Commercial Distribution

  • J011294288600 ()


  • Dental appliance fabrication material, ceramic
Triceram® Dentin CC 3+1, 40g / dental ceramic material
DENTAURUM GmbH & Co.KG
294-287-60
In Commercial Distribution

  • J011294287600 ()


  • Dental appliance fabrication material, ceramic
Triceram® Dentin CC 2+2, 40g / dental ceramic material
DENTAURUM GmbH & Co.KG
294-281-60
In Commercial Distribution

  • J011294281600 ()


  • Dental appliance fabrication material, ceramic
Triceram® Dentin CC 2+1, 40g / dental ceramic material
DENTAURUM GmbH & Co.KG
294-280-60
In Commercial Distribution

  • J011294280600 ()


  • Dental appliance fabrication material, ceramic
Irrigation Needle With Half Cutting Tips Utility Syringe 12 Cc
Proguard Health, Inc
PG-S12CC
In Commercial Distribution

  • D066PGS12CC2 ()
  • D066PGS12CC1 ()
  • D066PGS12CC0 ()
PG-S12CC

  • Dental irrigation/aspiration syringe
Detector holder for use of CC type detectors with WP1D
IBA Dosimetry GmbH
M9006290
In Commercial Distribution

  • EIBAM90062900 ()
DA07-500

  • Accelerator system quality assurance device
SET ZZ BASE NB-A-WSM CC 3.0 (White Scanmarker and screw). The ZZ BASE WSM (WHITE SCANMARKER) allows the user to record the implant position and inclination in the patient’s mouth or on the model.
ZIRKONZAHN SRL
ZBCD2433
In Commercial Distribution

  • D800ZBCD2433 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
Acrylic spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-322
Not in Commercial Distribution


  • Outer Diameter: 22 Millimeter
  • Total Volume: 5.7 Milliliter


  • Orbital sphere implant
Acrylic spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-320
Not in Commercial Distribution


  • Outer Diameter: 20 Millimeter
  • Total Volume: 3.6 Milliliter


  • Orbital sphere implant
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