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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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The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIO Biotite-H Implant System`s screw-form dental implant consist of machined titanium. Screw`s Diameter : Ø3.8mm, Ø4.1mm, Ø4.5mm, Ø4.8mm, Ø5.3mm. Length : 8.0mm, 10.0mm 12.0mm, 14.0mm
DIO Corporation
SAC 4816N
Not in Commercial Distribution

  • 08806195922651 ()

  • Ø4.8X6(1)mm NON
SAC 4816N

  • Screw endosteal dental implant, two-piece
The DIO SM Implant System is comprised of dental implant, Superstructure, Instruments for prosthetics and Surgical Instruments The DIO SM Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The superstructures consist or screws(Closing Screw, Coping Screw), abutments (Screw retained type, Cemented retainde type, Overdenture retainde type), Solid protect cap. The screws are made of commercial pure titanium, grade 4(ASTM F76) and Ti-6A1-4VELI(ASTM F136) intended to be usedin a narrow tooth gap after implant insertion and to protect exposed top of commercial pure titanium, grade 3 and grade 4(ASTM F76), Ti-6A1-4VELI(ASTM F136), white gold alloy, POM, PMMA. The intentions of each abutment are described in part 2.4. The protect cap is made of POM and intended to protect infecting other substances after solid abutment is fixed on the implant.
DIO Corporation
SAC 4815T(II)
Not in Commercial Distribution

  • 08806195922644 ()

  • Ø4.8X5.5(1.0)mm
SAC 4815T(II)

  • Screw endosteal dental implant, two-piece
The DIO SM Implant System is comprised of dental implant, Superstructure, Instruments for prosthetics and Surgical Instruments The DIO SM Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The superstructures consist or screws(Closing Screw, Coping Screw), abutments (Screw retained type, Cemented retainde type, Overdenture retainde type), Solid protect cap. The screws are made of commercial pure titanium, grade 4(ASTM F76) and Ti-6A1-4VELI(ASTM F136) intended to be usedin a narrow tooth gap after implant insertion and to protect exposed top of commercial pure titanium, grade 3 and grade 4(ASTM F76), Ti-6A1-4VELI(ASTM F136), white gold alloy, POM, PMMA. The intentions of each abutment are described in part 2.4. The protect cap is made of POM and intended to protect infecting other substances after solid abutment is fixed on the implant.
DIO Corporation
SAC 4815N(II)
Not in Commercial Distribution

  • 08806195922637 ()

  • Ø4.8X5.5(1.0)mm
SAC 4815N(II)

  • Screw endosteal dental implant, two-piece
The DIO SM Implant System is comprised of dental implant, Superstructure, Instruments for prosthetics and Surgical Instruments The DIO SM Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The superstructures consist or screws(Closing Screw, Coping Screw), abutments (Screw retained type, Cemented retainde type, Overdenture retainde type), Solid protect cap. The screws are made of commercial pure titanium, grade 4(ASTM F76) and Ti-6A1-4VELI(ASTM F136) intended to be usedin a narrow tooth gap after implant insertion and to protect exposed top of commercial pure titanium, grade 3 and grade 4(ASTM F76), Ti-6A1-4VELI(ASTM F136), white gold alloy, POM, PMMA. The intentions of each abutment are described in part 2.4. The protect cap is made of POM and intended to protect infecting other substances after solid abutment is fixed on the implant.
DIO Corporation
SAC 4814T(II)
Not in Commercial Distribution

  • 08806195922620 ()

  • Ø4.8X4.0(1.0)mm
SAC 4814T(II)

  • Screw endosteal dental implant, two-piece
The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIO Biotite-H Implant System`s screw-form dental implant consist of machined titanium. Screw`s Diameter : Ø3.8mm, Ø4.1mm, Ø4.5mm, Ø4.8mm, Ø5.3mm. Length : 8.0mm, 10.0mm 12.0mm, 14.0mm
DIO Corporation
SAC 4814T
Not in Commercial Distribution

  • 08806195922613 ()

  • Ø4.8X4(1)mm TORX
SAC 4814T

  • Screw endosteal dental implant, two-piece
The DIO SM Implant System is comprised of dental implant, Superstructure, Instruments for prosthetics and Surgical Instruments The DIO SM Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The superstructures consist or screws(Closing Screw, Coping Screw), abutments (Screw retained type, Cemented retainde type, Overdenture retainde type), Solid protect cap. The screws are made of commercial pure titanium, grade 4(ASTM F76) and Ti-6A1-4VELI(ASTM F136) intended to be usedin a narrow tooth gap after implant insertion and to protect exposed top of commercial pure titanium, grade 3 and grade 4(ASTM F76), Ti-6A1-4VELI(ASTM F136), white gold alloy, POM, PMMA. The intentions of each abutment are described in part 2.4. The protect cap is made of POM and intended to protect infecting other substances after solid abutment is fixed on the implant.
DIO Corporation
SAC 4814N(II)
Not in Commercial Distribution

  • 08806195922606 ()

  • Ø4.8X4.0(1.0)mm
SAC 4814N(II)

  • Screw endosteal dental implant, two-piece
The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIO Biotite-H Implant System`s screw-form dental implant consist of machined titanium. Screw`s Diameter : Ø3.8mm, Ø4.1mm, Ø4.5mm, Ø4.8mm, Ø5.3mm. Length : 8.0mm, 10.0mm 12.0mm, 14.0mm
DIO Corporation
SAC 4814N
Not in Commercial Distribution

  • 08806195922590 ()

  • Ø4.8X4(1)mm NON
SAC 4814N

  • Screw endosteal dental implant, two-piece
The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIO Biotite-H Implant System`s screw-form dental implant consist of machined titanium. Screw`s Diameter : Ø3.8mm, Ø4.1mm, Ø4.5mm, Ø4.8mm, Ø5.3mm. Length : 8.0mm, 10.0mm 12.0mm, 14.0mm
DIO Corporation
SAC 3966T
Not in Commercial Distribution

  • 08806195922583 ()

  • Ø3.9X6(6)mm TORX
SAC 3966T

  • Screw endosteal dental implant, two-piece
The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIO Biotite-H Implant System`s screw-form dental implant consist of machined titanium. Screw`s Diameter : Ø3.8mm, Ø4.1mm, Ø4.5mm, Ø4.8mm, Ø5.3mm. Length : 8.0mm, 10.0mm 12.0mm, 14.0mm
DIO Corporation
SAC 3966N
Not in Commercial Distribution

  • 08806195922576 ()

  • Ø3.9X6(6)mm NON
SAC 3966N

  • Screw endosteal dental implant, two-piece
The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIO Biotite-H Implant System`s screw-form dental implant consist of machined titanium. Screw`s Diameter : Ø3.8mm, Ø4.1mm, Ø4.5mm, Ø4.8mm, Ø5.3mm. Length : 8.0mm, 10.0mm 12.0mm, 14.0mm
DIO Corporation
SAC 3964T
Not in Commercial Distribution

  • 08806195922569 ()

  • Ø3.9X4(6)mm TORX
SAC 3964T

  • Screw endosteal dental implant, two-piece
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