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Noris Medical Dental Implants System is intended to replace missing tooth teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The procedure can be accomplished in a one-stage or two-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Noris Medical MBI Dental Implant System is One-Piece, self-tapping Implant, with integrated ball attachment, for singlestage implantation to stabilize a tissue-supported denture. MBI is designed for placement in a very narrow ridge.

Noris Medical MBI Dental Implant System is One-Piece, self-tapping Implant, with integrated ball attachment, for singlestage implantation to stabilize a tissue-supported denture. MBI is designed for placement in a very narrow ridge.

This document is an FDA 510(k) clearance letter for the Noris Medical MBI Dental Implant System. It discusses the regulatory approval, but it does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence to a predicate device, not on specific performance metrics or studies proving those metrics.

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