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The NobelDirect™ OD Implant is a root form endosseous implant intended to provide immediate retention for removable tissue supported lower dentures in fully edentulous patients.

The NobelDirect™ OD Implant is a root form endosseous implant intended to provide immediate retention for a removable tissue supported overdenture. The NobelDirect™ OD Implant is intended for placement in the interforaminal area of the anterior mandible for the fully edentulous lower arch.

Nobel Biocare's NobelDirect™ OD Implant is a threaded one-piece root form endossions with an integrated ball attachment designed for one-stage surgical procedures and overdenture restorations. The integratou ball attablimont as intended to provide immediate retention for removable tissue supported lower overdentures in fully edentulous jaws.

Nobel Biocare's NobelDirect™ OD Implant can be placed in an edentulous arch or piaced simultaneously Nobel Diocare 3 Nobel Biocare's Nobel Biocare's NobelDirect™ OD Implant in immediate function applications, it is essential to obtain primary implant stability. Nobel Biocare's Gold Cap for Ball Attachment is to be utilized with the NobelDirect™ OD Implant.

Nobel Biocare's NobelDirect™ OD Implant is machined from titanium and is available with a straight or tapered contour. The NobelDirect™ OD Implant has a surface treatment that consists of a titanium oxide layer (TiUnite) that extends over the implant threads and onto the implant collar.

This 510(k) premarket notification is for a dental implant, the NobelDirect™ OD Implant. The provided document does not contain information regarding specific acceptance criteria, a study proving device performance against such criteria, sample sizes for test or training sets, ground truth establishment methods, or details about expert involvement. This type of information is typically found in performance testing sections of a 510(k) submission, which are not present in this excerpt.

The document primarily focuses on:

• Device Description: What the NobelDirect™ OD implant is (threaded one-piece root form endosseous implant with an integrated ball attachment).
• Intended Use: For one-stage surgical procedures and overdenture restorations, providing immediate retention for removable tissue-supported lower overdentures in fully edentulous jaws.
• Indications for Use: Specifically stated as "a root form endosseous implant intended to provide immediate retention for removable tissue supported lower dentures in fully edentulous patients." The "Indications for Use" form also specifies "immediate retention for a removable tissue supported overdenture. The NobelDirect™ OD implant is indicated for use in the interforaminal area of the anterior mandible for the fully edentulous lower arch."
• Substantial Equivalence: Listing legally marketed predicate devices (Brånemark System Implants K022562 and Replace One-Piece Implants K023952) to establish substantial equivalence.
• FDA Clearance Letter: Confirming that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and study details based on the provided text.

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