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510(k) Data Aggregation
K Number
K092261Device Name
DEFCON TSA/TSH DENTAL IMPLANT SYSTEM
Manufacturer
Date Cleared
2010-07-23
(360 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMPLADENT, S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DEFCON TSA/TSH implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients.
DEFCON TSA/TSH implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations.
Implants are intended for immediate loading on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function if the requirement detailed in the surgical manual is satisfied. When placing implants in the posterior region, we recommend using only large diameter (Ø6.0 mm and above) implants.
Specific indications for small diameter (Ø3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.
Device Description
DEFCON TSA / TSH dental implant systems are threaded, root-form endosseous implants of various diameters and lengths and corresponding abutments. Implants are composed of Titanium commercially pure, feature different implant to abutment connection options and are available with modified surfaces to promote improved osseointegration. Implant abutments are composed of Titanium commercially pure, Titanium alloy 6Al 4V and POM-C.
Primary stability, adequate osseointegration and mechanical performance of the implant connection are fundamental to implant success. Device design characteristics including the thread profile, geometry, surface finish and crestal characteristics are based on these concepts.
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