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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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Bone Screw, 5.5mm x 30mm. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
Seaspine Orthopedics Corporation
55-5530
In Commercial Distribution

  • 10889981037390 ()

  • 5.5mm Dia x 30mm
55-5530

  • Vertebral body prosthesis, non-sterile
Bone Screw, 5.5mm x 25mm. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
Seaspine Orthopedics Corporation
55-5525
In Commercial Distribution

  • 10889981037383 ()

  • 5.5mm Dia x 25mm
55-5525

  • Vertebral body prosthesis, non-sterile
Bone Screw, 5.5mm x 20mm. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
Seaspine Orthopedics Corporation
55-5520
In Commercial Distribution

  • 10889981037376 ()

  • 5.5mm Dia x 20mm
55-5520

  • Vertebral body prosthesis, non-sterile
Bone Screw, 5.5mm x 15mm. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
Seaspine Orthopedics Corporation
55-5515
Not in Commercial Distribution

  • 10889981037369 ()

  • 5.5mm Dia x 15mm
55-5515

  • Vertebral body prosthesis, non-sterile
RetroMTA is an ideal material for vital pulp therapy and root repair. Setting is 150 seconds (W/P=1/0.28). There is no heavy metal contents in it and no discoloration after application. RetroMTA has a wide variety of clinical indications such as for pulp capping or pulpotomy for deciduous and young teeth, apexification and base cement for prevention of discoloration or for tooth whitening procedure.
BioMTA
RM02
In Commercial Distribution

  • 08800027200054 ()


  • Endodontic filling/sealing material
RetroMTA is an ideal material for vital pulp therapy and root repair. Setting is 150 seconds (W/P=1/0.28). There is no heavy metal contents in it and no discoloration after application. RetroMTA has a wide variety of clinical indications such as for pulp capping or pulpotomy for deciduous and young teeth, apexification and base cement for prevention of discoloration or for tooth whitening procedure.
BioMTA
RM08
In Commercial Distribution

  • 08800027200047 ()


  • Endodontic filling/sealing material
CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of a flowable paste and can be immediately applied inside the root canal using a disposable tip. material, and a thickening agent. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.
Meta Biomed Co., Ltd.
9484
In Commercial Distribution

  • 08806387894841 ()


  • Endodontic filling/sealing material
CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of a flowable paste and can be immediately applied inside the root canal using a disposable tip. material, and a thickening agent. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.
Meta Biomed Co., Ltd.
9481
In Commercial Distribution

  • 08806387894810 ()


  • Endodontic filling/sealing material
CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of a flowable paste and can be immediately applied inside the root canal using a disposable tip. material, and a thickening agent. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.
Meta Biomed Co., Ltd.
9412
In Commercial Distribution

  • 08806387894124 ()


  • Endodontic filling/sealing material
CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of a flowable paste and can be immediately applied inside the root canal using a disposable tip. material, and a thickening agent. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.
Meta Biomed Co., Ltd.
6003
In Commercial Distribution

  • 08806387860037 ()


  • Endodontic filling/sealing material
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