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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® Certain® 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 internal hex connections. Additionally, the implants are offered in an expanded platform, lateralized 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 does not contain specific acceptance criteria or a detailed study description with performance metrics for the 3i OSSEOTITE® Certain® Dental Implants in the format requested.

Instead, the document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to previously cleared predicate devices. The "Performance" section explicitly states: "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act."

The document mentions "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." However, no specific results, acceptance criteria, or a detailed study design from this laboratory testing are provided.

The text also refers to previous 510(k) clearances for specific performance claims (enhanced performance in poor bone, early loading, use in smokers, immediate loading) based on "OSSEOTITE clinical data in the respective submissions." However, the details of these studies and their acceptance criteria are not included in this document.

Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert opinions, or MRMC studies because this information is not present in the provided text. The document's purpose is to show substantial equivalence, not to present a detailed performance study against specific acceptance criteria.

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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).

Ask a specific question about this device