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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.

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The provided text is a 510(k) premarket notification for a dental implant system. This type of document issues a substantial equivalence determination for a medical device but does not contain acceptance criteria or study results for device performance.

Therefore, I cannot extract the requested information based on the provided text. The document primarily focuses on regulatory approval and classification, not detailed performance metrics and supporting studies.

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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.

Kwan hexagonal Abutment Implant System (HAIS)

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental implant system. It acknowledges the device's substantial equivalence to previously marketed devices and outlines regulatory information. However, it does not contain any information about acceptance criteria, study details, performance data, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

Ask a specific question about this device