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3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

In addition, when a minimum of 4 implants, ≥ 10mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.

The 3i OSSEOTITE® Dental Implants are provided with the proprietary OSSEOTITE acid-etched surface which has been in commercial distribution since market clearance in 1995. Implants are offered in tapered and parallel-walled/straight designs, each design providing offerings for external hex connections. Additionally, the implants are offered in a trans-gingival design with an internal connection Implants are offered in diameters of 3.25, 3.75, 4.0, 5.0, and 6.0 in varying lengths from 7 mm to 20 mm. size appropriate cover screws are offered with each implant.

The provided text is related to a 510(k) premarket notification for "3i OSSEOTITE® Dental Implants." However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria with numerical results.

Instead, the document focuses on:

• Substantial Equivalence: The primary assertion is that the new device is substantially equivalent to previously cleared predicate devices (K874590, K935544, K972444, K980549, K983347, K992334, K014235, K022009, K030164, K033430, K051461).
• Performance Testing: It states that "Laboratory testing was conducted to determine device functionality and conformance to design input requirements, as well as FDA's Class II special controls guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Risk analysis was conducted in accordance with ISO 14971."
• Previous Clinical Data: It mentions that "Specific performance claims for enhanced performance in poor bone (K980549), early loading (K983347), and use in smokers (K022009), and immediate loading (K030164) have received market clearance based on the OSSEOTITE clinical data in the respective submissions." This indicates that clinical data from previous submissions was used to support specific claims, but no new study details or acceptance criteria for this specific 510(k) submission are presented..

Therefore, I cannot populate the requested table and details because the information is not present in the provided text. The document relies on substantial equivalence to previously cleared devices and refers to prior clinical data from those predicate devices for performance claims, rather than presenting new acceptance criteria and a study to meet them for this specific 510(k).

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