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510(k) Data Aggregation
K Number
K974106Device Name
ICON IMPLANT SYSTEM
Manufacturer
Date Cleared
1998-06-01
(213 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
BIO SCIENCE TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Icon Implant System is intended for use in either partially or fully edentulous mandibles and maxillae in the following areas:
- Support of fixed (cemented) restorations utilizing multiple abutments;
- Support of fixed detachable (screw retained) prosthetics utilizing multiple abutments;
- Overdenture retention by means of a ball overdenture attachment, o-ring attachment, dalla bona, or hader bar;
- Terminal or intermediate abutment support for fixed bridgework;
- Free standing restorations without involvement of adjacent dentition when the external hex is engaged.
Device Description
The Bio Science Technologies, Inc.'s Icon Implant System consists of a screw implant and a cover screw which are contained within a titanium (CP) canister. An actual implant is provided for the Reviewer. The implant and cover screw are nearly identical to the Branemark System® Mk II Self-Tapping Fixture (K945398) manufactured by Nobelpharma USA, Inc.
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