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Found 4 results
510(k) Data Aggregation
K Number
K061169Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer
NORTHERN IMPLANTS, LLC
Date Cleared
2006-06-20
(54 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
NORTHERN IMPLANTS, LLC
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.
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K Number
K053478Device Name
ENDOSSEOUS DENTAL IMPLANT SYSTEM
Manufacturer
NORTHERN IMPLANTS, LLC
Date Cleared
2006-04-05
(112 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
NORTHERN IMPLANTS, LLC
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.
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K Number
K052490Device Name
ENDOSSEOUS DENTAL IMPLANT SYSTEM
Manufacturer
NORTHERN IMPLANTS, LLC
Date Cleared
2005-12-08
(87 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
NORTHERN IMPLANTS, LLC
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 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 NSI Implant System is intended 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.
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K Number
K033171Device Name
NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING
Manufacturer
NORTHERN IMPLANTS, LLC
Date Cleared
2004-04-27
(210 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
NORTHERN IMPLANTS, LLC
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 placement and function in the mandible on splinted multiple-unit implant restorations supported by a minimum of four implants anterior to the mental foramen when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
Device Description
The NSI Implant System is intended for implantation 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 in the mandible on splinted multipleunit implant restorations anterior to the mental foramen when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
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