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The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
Inspire Medical Systems, Inc.
900-007-003
In Commercial Distribution
- 10855728005465 ()
3028
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
Inspire Medical Systems, Inc.
900-007-001
In Commercial Distribution
- 10855728005366 ()
3028
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
Inspire Medical Systems, Inc.
900-007-019
In Commercial Distribution
- 10810098650264 ()
3028
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
Inspire Medical Systems, Inc.
900-007-017
In Commercial Distribution
- 10810098650141 ()
3028
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgical Instruments.
The Protein Implants is an integrated system of endosseous dental implants which designed to protect main implant from immediate loading during osteointegration period, to increase indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sandblasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implants which provide the clinician to maintain the patients' gingival contour.
The Implants have the diameter(2.0/2.5mm) and length.(8/10/12/14mm).
The superstructures consist of Protein Cemented Abutment, Ball Cap and Healing Cap. The Protein Cemented Abutments are made of titanium and intended for cement-retained restorations where conventional crown & bridge techniques are required. It can be used for single or multiple unit restorations. Ball Cap intended to retain the O-ring inside of the denture. Healing Cap is fixed on the ball type fixture to protect the direct pressure reduce the motion of
fixture.
The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation.
The implants are gamma sterilized and intended to single use. And the surgical tools are nongamma sterilized and have to be sterilized by user before using.
DIO Corporation
MFB 25414
Not in Commercial Distribution
- 08806195912515 ()
- ® Ø2.5X14mm
MFB 25414
- Screw endosteal dental implant, two-piece
DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgical Instruments.
The Protein Implants is an integrated system of endosseous dental implants which designed to protect main implant from immediate loading during osteointegration period, to increase indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sandblasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implants which provide the clinician to maintain the patients' gingival contour.
The Implants have the diameter(2.0/2.5mm) and length.(8/10/12/14mm).
The superstructures consist of Protein Cemented Abutment, Ball Cap and Healing Cap. The Protein Cemented Abutments are made of titanium and intended for cement-retained restorations where conventional crown & bridge techniques are required. It can be used for single or multiple unit restorations. Ball Cap intended to retain the O-ring inside of the denture. Healing Cap is fixed on the ball type fixture to protect the direct pressure reduce the motion of
fixture.
The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation.
The implants are gamma sterilized and intended to single use. And the surgical tools are nongamma sterilized and have to be sterilized by user before using.
DIO Corporation
MFB 25412
Not in Commercial Distribution
- 08806195912508 ()
- ® Ø2.5X12mm
MFB 25412
- Screw endosteal dental implant, two-piece
DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgical Instruments.
The Protein Implants is an integrated system of endosseous dental implants which designed to protect main implant from immediate loading during osteointegration period, to increase indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sandblasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implants which provide the clinician to maintain the patients' gingival contour.
The Implants have the diameter(2.0/2.5mm) and length.(8/10/12/14mm).
The superstructures consist of Protein Cemented Abutment, Ball Cap and Healing Cap. The Protein Cemented Abutments are made of titanium and intended for cement-retained restorations where conventional crown & bridge techniques are required. It can be used for single or multiple unit restorations. Ball Cap intended to retain the O-ring inside of the denture. Healing Cap is fixed on the ball type fixture to protect the direct pressure reduce the motion of
fixture.
The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation.
The implants are gamma sterilized and intended to single use. And the surgical tools are nongamma sterilized and have to be sterilized by user before using.
DIO Corporation
MFB 25410
Not in Commercial Distribution
- 08806195912492 ()
- ® Ø2.5X10mm
MFB 25410
- Screw endosteal dental implant, two-piece
DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgical Instruments.
The Protein Implants is an integrated system of endosseous dental implants which designed to protect main implant from immediate loading during osteointegration period, to increase indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sandblasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implants which provide the clinician to maintain the patients' gingival contour.
The Implants have the diameter(2.0/2.5mm) and length.(8/10/12/14mm).
The superstructures consist of Protein Cemented Abutment, Ball Cap and Healing Cap. The Protein Cemented Abutments are made of titanium and intended for cement-retained restorations where conventional crown & bridge techniques are required. It can be used for single or multiple unit restorations. Ball Cap intended to retain the O-ring inside of the denture. Healing Cap is fixed on the ball type fixture to protect the direct pressure reduce the motion of
fixture.
The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation.
The implants are gamma sterilized and intended to single use. And the surgical tools are nongamma sterilized and have to be sterilized by user before using.
DIO Corporation
MFB 25408
Not in Commercial Distribution
- 08806195912485 ()
- ® Ø2.5X8mm
MFB 25408
- Screw endosteal dental implant, two-piece
DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgical Instruments.
The Protein Implants is an integrated system of endosseous dental implants which designed to protect main implant from immediate loading during osteointegration period, to increase indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sandblasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implants which provide the clinician to maintain the patients' gingival contour.
The Implants have the diameter(2.0/2.5mm) and length.(8/10/12/14mm).
The superstructures consist of Protein Cemented Abutment, Ball Cap and Healing Cap. The Protein Cemented Abutments are made of titanium and intended for cement-retained restorations where conventional crown & bridge techniques are required. It can be used for single or multiple unit restorations. Ball Cap intended to retain the O-ring inside of the denture. Healing Cap is fixed on the ball type fixture to protect the direct pressure reduce the motion of
fixture.
The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation.
The implants are gamma sterilized and intended to single use. And the surgical tools are nongamma sterilized and have to be sterilized by user before using.
DIO Corporation
MFB 25214
Not in Commercial Distribution
- 08806195912478 ()
- ® Ø2.5X14mm
MFB 25214
- Screw endosteal dental implant, two-piece
DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgical Instruments.
The Protein Implants is an integrated system of endosseous dental implants which designed to protect main implant from immediate loading during osteointegration period, to increase indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sandblasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implants which provide the clinician to maintain the patients' gingival contour.
The Implants have the diameter(2.0/2.5mm) and length.(8/10/12/14mm).
The superstructures consist of Protein Cemented Abutment, Ball Cap and Healing Cap. The Protein Cemented Abutments are made of titanium and intended for cement-retained restorations where conventional crown & bridge techniques are required. It can be used for single or multiple unit restorations. Ball Cap intended to retain the O-ring inside of the denture. Healing Cap is fixed on the ball type fixture to protect the direct pressure reduce the motion of
fixture.
The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation.
The implants are gamma sterilized and intended to single use. And the surgical tools are nongamma sterilized and have to be sterilized by user before using.
DIO Corporation
MFB 25212
Not in Commercial Distribution
- 08806195912461 ()
- ® Ø2.5X12mm
MFB 25212
- Screw endosteal dental implant, two-piece