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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 restoration and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures.

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

The PREVAIL implants are the same as the OSSEOTITE IOL implants [K031632] designed with an internal and external hex connection. The PREVAIL implants will have a lateralized seating surface on both the internal and external hex implants. The PREVAIL implants will be manufactured from Titanium Alloy per ASTM F-136 or Commercially Pure Titanium per ASTM F-67.

The PREVAIL implants will be available in lengths of 8.5mm to 15.0mm with a diameter of 3.4mm, 4.0mm, 5.0mm, and 6.0mm.

This appears to be a 510(k) premarket notification for a dental implant device, not a study evaluating device performance against acceptance criteria. The document describes a device modification and asserts substantial equivalence to previously cleared devices. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document because it is not a performance study report.

The document primarily focuses on regulatory approval based on equivalence to predicate devices, rather than clinical or technical performance testing beyond what is necessary to support the claim of equivalence.

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