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510(k) Data Aggregation
K Number
K080129Device Name
SECURE IMPLANT SYSTEM (2.5/3.0MM)
Manufacturer
DIO DEPARTMENT DSI, INC.
Date Cleared
2008-05-30
(134 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DIO DEPARTMENT DSI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Secure Implant System(2.5/3.0mm) is designed for use in dental implant surgery and is intended for use in a manner in which the implants integrate with the bone(osseointegration). It is intended to provide immediate transitional splinting stability or intrabony long-term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients
Device Description
Sccure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 2.5 and 3.0mm, and lengths from 8mm to 16mm.
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K Number
K073070Device Name
DIO BIOTITE-H IMPLANT SYSTEM
Manufacturer
DIO DEPARTMENT DSI, INC.
Date Cleared
2008-05-16
(199 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DIO DEPARTMENT DSI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DIO Biotite-H Implant System is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Also, angled abutments on small diameter implants (3.8mm) of the DIO Biotite-H Implant System are intended for the anterior region of the mouth and not intended for the posterior region of the mouth due to possible failure of the implant.
Device Description
The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIO BIOTITE -H Implant System is designed for conventional two-stage procedures for single and multiple unit prosthetics. The DIO Biotite-H Implant System's screw-form dental implant consist of machined titanium. Screw's Diameter: Ø 3.8mm, Ø 4.1mm, Ø 4.5mm, Ø 4.8mm, Ø 5.3mm. Length: 8.0mm, 10.mm, 14.0mm. The implant's raw material is titanium and its alloys for surgical implant applications (as perASTM-F-67, A~STM-F-136). The special implant surface is consists of 100% calcium phosphate(CaHPO42H2O). BioTite-H Implant System is an electrochemically deposited calcium phosphate coating based upon a biomimetic process in which implants are coated in an electrolytic bath with a 15+/- 5um thin bioactive layer of a calcium phosphate composite. Biotite -- H Implant System composed of the two calciumphosphates brushite(>95% )and HA(<5%).
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K Number
K080128Device Name
SM-EXTRA WIDE (RBM) IMPLANT SYSTEM
Manufacturer
DIO DEPARTMENT DSI, INC.
Date Cleared
2008-05-14
(118 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DIO DEPARTMENT DSI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SM-Extra Wide(RBM) Implant Fixture is intended to be surgically placed in the maxillary or mandivular molar areas for the purpose of providing prosthetic support for dental restoration (Crown, Bridges, and overdentures) in partially or fully edentulous individuals. These Fixtures can be used where smaller implants have failed.
Device Description
SM-Extra Wide(RBM) Implant System consists of SM-Extra Wide(RBM) fixtures, abutments, prosthetics and surgical instruments.
SM-Extra Wide(RBM) Implant Fixtures are made of commercial pure titanium, grade 4 which have a sand-blasted, RBM(Resorbable Blast Media) treated surface. These fixtures are the onestage implant and two-stage implant and surgically inserted in the maxillary or mandibular molar areas or where smaller implants have failed.
These fixtures are the integrated system of endosseous dental implants which designed to Provide prosthetics support for dental restoration (Crown, Bridges, and overdentures) in partially or fully edentulous individuals.
The screw, cemented and overdenture retained restoration, other superstructure and instruments for prosthetics that used when the SM-Extra Wide implants is surged are same with each standard type of DIO SM Implant System.
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K Number
K070570Device Name
DIO IMPLANT SYSTEM
Manufacturer
DIO DEPARTMENT DSI, INC.
Date Cleared
2008-04-15
(412 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DIO DEPARTMENT DSI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.
Device Description
The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These implants are surgically inserted into the upper and/or lower jawbone, and serve as a substitute or replacement tooth root providing a stable foundation for restorations.
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K Number
K080126Device Name
DIO PROTEM IMPLANT SYSTEM
Manufacturer
DIO DEPARTMENT DSI, INC.
Date Cleared
2008-04-11
(85 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DIO DEPARTMENT DSI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DIO Protem Implant Systems are intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.
Device Description
DIO Protem Implant System consists of Protem Implants, Superstructure, Prosthetics and Surgical Instruments. The Protem 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 Protem Cemented Abutment, Ball Cap and Healing Cap. The Protem 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.
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K Number
K070569Device Name
SM INTERNAL./EXTERNAL IMPLANT SYSTEM
Manufacturer
DIO DEPARTMENT DSI, INC.
Date Cleared
2007-11-08
(253 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DIO DEPARTMENT DSI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SM Dental implant system is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. The SM Dental implant system is intended for immediate placement and function on singletooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients 4 or more implants must be used.
Device Description
SM® Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 3.8, 4.5 and 5.3mm, and lengths from 8mm to 14mm. It is placed via one or two stage surgery and the functional loading can be from immediate to delay.
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K Number
K070568Device Name
DIO PROTEM IMPLANT SYSTEM
Manufacturer
DIO DEPARTMENT DSI, INC.
Date Cleared
2007-05-25
(86 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DIO DEPARTMENT DSI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DIO Protem Implant Systems are intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.
Device Description
DIO Protem Implant System is a root-form threaded dental implant made of titanium alloy. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 2.0 and 2.5mm, and lengths from 8mm to 14mm. It is placed via one stage surgery and the functional loading can be from immediate to delay.
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K Number
K061797Device Name
SM IMPLANT SYSTEMS
Manufacturer
DIO DEPARTMENT DSI, INC.
Date Cleared
2006-09-01
(67 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DIO DEPARTMENT DSI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SM® Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.
Device Description
The SM Implant System is a root-form threaded dental implant made of Grade 4 titanium. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 3.8, 4.5, and 5.3 mm, and lengths from 8mm to 14 mm. It is placed via one or two stage surgery and the functional loading can be from immediate to delay.
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