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510(k) Data Aggregation
K Number
K013383Device Name
BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM
Manufacturer
Date Cleared
2002-01-10
(90 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
BIOMEDICAL IMPLANT TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For implantation into the fully or partially edentulous ridge for the support of a dental prosthesis or for single tooth replacement, in a single stage surgical procedure.
The product is intended to be implanted with no-load conditions for 8-10 weeks after implantation.
Device Description
Not Found
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K Number
K962753Device Name
KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS)
Manufacturer
Date Cleared
1997-05-19
(308 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
BIOMEDICAL IMPLANT TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Kwan HAIS is intended for single tooth replacement, as an intermediate abutment on long span bridgework, as distal abutments on free end edentulous areas to be restored with fixed bridgework, to support over dentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxilla. The HAIS is intended to be used in single stage and two stage procedures.
Device Description
Kwan hexagonal Abutment Implant System (HAIS)
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