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• For Implantation into any area of the fully edentulous maxilla and mandible for the support of a removable or fixed dental prosthesis
• For Implantation into any area of the partially edentulous maxilla and mandible for the support of a removable or fixed dental prosthesis
• For single tooth or multiple unit prosthesis

The modification of the Blue Sky Bio Dental Implant System consists of root form dental implants of various lengths and diameters and associated abutment systems, which provide the clinician with cement retained and overdenture-type restorative options. Modifications to the existing system do not introduce new issues of safety or efficacy. The implants and components are supplied sterile or not sterile and are labeled accordingly. The system is suitable for a one-stage and two-stage protocol. The Implant system is not intended for immediate loading.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for the Blue Sky Bio Dental Implant System, detailing its general information, device description, intended use, and the FDA's letter of substantial equivalence. It does not include any performance data, study designs, sample sizes, ground truth establishment, or expert evaluations.

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

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