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The Rescue Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.

Rescue Internal Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Rescue Internal Implant Fixture Systems consist of two-stage, root-form dental implants, associated with abutment systems, and the instruments.

The provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria for the "Rescue Internal Dental Implant System."

Instead, the document is a 510(k) Premarket Notification Summary for the device, which aims to establish substantial equivalence to a predicate device. This type of submission generally focuses on comparing the new device's design, materials, and indications for use to an already legally marketed device, rather than presenting new performance data against specific acceptance criteria.

The relevant sections of the document explicitly state:

• "FDA has not established a performance standard applicable to endosseous... The materials in the Rescue Internal Implant System meet applicable implants." (Section 8, page 1) This indicates that there are no specific FDA-mandated performance standards or acceptance criteria for this type of device that would necessitate a study to meet them.
• "The noted difference in the design and material does not effectively change the performance of the device." (Section 11, page 1) This statement, along with the comparison table, emphasizes that the justification for market clearance is based on the new device being substantially equivalent to a predicate, implying that its performance is presumed to be similar without requiring new performance studies against specific criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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