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510(k) Data Aggregation
K Number
K083141Device Name
SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM
Manufacturer
Date Cleared
2008-11-07
(15 days)
Product Code
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
SIMPACT LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Simpact Dental Implant System is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained terminal or intermediate abutment support for fixed bridgework.
The Simpact implant is a threaded/tapered internal connection implant. The Simpact implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction, into the extraction socket.
The Simpact implant is intended for immediate provisional loading when primary stability and proper occlusion are present. Immediate Provisionalization is defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for the placement of an interim prosthesis with occlusal contact with the opposing dentition, at the same clinical visit of implant placement. The Simpact implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications.
Device Description
The SIMPACT Endosseous Dental Implant System, Line Extension
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K Number
K081226Device Name
SIMPACT IMPLANT SYSTEM
Manufacturer
Date Cleared
2008-09-12
(135 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SIMPACT LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Simpact Dental Implant System is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained terminal or intermediate abutment support for fixed bridgework.
The Simpact implant is a threaded/tapered internal connection implant. The Simpact implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction, into the extraction socket.
The Simpact implant is intended for immediate provisional loading when primary stability and proper occlusion are present. Immediate Provisionalization is defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for the placement of an interim prosthesis with occlusal contact with the opposing dentition, at the same clinical visit of implant placement. The Simpact implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications.
Device Description
The SIMPACT Endosseous Dental Implant System.
The Simpact implant is a threaded/tapered internal connection implant.
Ask a Question
Ask a specific question about this device
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