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510(k) Data Aggregation
K Number
K102635Device Name
APOLONIA LASER IMPLANT SYSTEM
Manufacturer
CSM IMPLANT CO., LTD
Date Cleared
2011-03-22
(190 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
CSM IMPLANT CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CSM Implants are intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed loading.
Device Description
The CSM submerged-L Implant System includes various one-stage Fixtures and two-stage Fixtures made of titanium. These implants are surgically inserted into the upper and/or lower jawbone and serve as a tooth root replacement providing a stable foundation for restorations. This product is a fixture and an abutment prosthetic dentistry material which are dental implant infrastructures. The connection with the abutment is inserted in bones as internal connection (the morse taper 11° and Hexagon type) method. A connection will restore mastication function of the patient who has difficulties due to damage of the natural tooth and function as a supporting the prosthetic dentistry material such as artificial tooth.
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