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Found 5 results
510(k) Data Aggregation
K Number
K093562Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer
SOUTHERN IMPLANTS, INC.
Date Cleared
2010-10-14
(330 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SOUTHERN IMPLANTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zygomatic implant is intended to be implanted in the upper jaw arch to provide support for fixed or removable dental prostheses in patients with fully or partially edentulous maxillae.
Device Description
The Zygomatic implant is intended to be implanted in the upper jay arch to provide support for fixed or removable dental prostheses in patients with fully or partially edentulous maxillae.
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K Number
K082651Device Name
ENDOSSEOUS DENTAL IMPLANT SYSTEM
Manufacturer
SOUTHERN IMPLANTS, INC.
Date Cleared
2008-12-22
(101 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SOUTHERN IMPLANTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 24° Co-Axis implant is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. This implant is not intended, nor should it be used, in conjunction with an angled abutment.
Device Description
The 24° Co-Axis implant is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. This implant is not intended, nor should it be used, in conjunction with an angled abutment. The physical properties and designs of the additional implants and accessories in the NSI Hexed and Non-Hexed Implant System were compared with legally marketed predicate devices. The technological characteristics were comparable.
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K Number
K071161Device Name
ENDOSSEOUS DENTAL IMPLANT SYSTEM
Manufacturer
SOUTHERN IMPLANTS, INC.
Date Cleared
2007-11-16
(204 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SOUTHERN IMPLANTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
The NSI MAX Implant System is intended for implantation in the maxilla or mandibular molar region where bone exists and the surgeon has determined a wider implant would increase the probability of placement of a narrow implant, or increased surgical procedures leading to complications. This MAX implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It also adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
Device Description
The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
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K Number
K070841Device Name
ENDOSSEOUS DENTAL IMPLANT SYSTEM
Manufacturer
SOUTHERN IMPLANTS, INC.
Date Cleared
2007-06-21
(86 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SOUTHERN IMPLANTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
Device Description
The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
The 4.0 co-axis implant is not intended, nor should it be used, in conjunction with an angled abutment.
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K Number
K070905Device Name
ENDOSSEOUS DENTAL IMPLANT SYSTEM
Manufacturer
SOUTHERN IMPLANTS, INC.
Date Cleared
2007-05-24
(52 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SOUTHERN IMPLANTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prosteses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
Device Description
The NSI Implant System is intended to the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
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