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The intended use for these devices is to serve as support for prosthetic devices to restore patient chewing function.

The Steri-Oss Replace Cylindrical Implant is designed to serve as support for prosthetic devices to restore patient chewing function. Natural dentition is composed of a root (subgingival) and a crown (supragingival). The implant is designed to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial dentition and the prosthetic device is designed to serve as the crown. The implants are 3.25, 4.3, 5.0 or 6.0 mm in diameter and from 10 - 16 mm in length and are composed of titanium. They are tapered, cylindrical and have a hexed head. The implants may be non-coated or coated (HA or TPS). The Replace Cylindrical Implants utilize color coding.

The provided document is a 510(k) premarket notification for a medical device (Steri-Oss Replace Cylindrical Implants). It does not contain any information about acceptance criteria or a study proving device performance against such criteria.

The document states "Performance Data: Not applicable" (page 2 of 2 in {1}). This indicates that no specific performance studies were included or deemed necessary for this particular 510(k) submission, likely because substantial equivalence was claimed to a predicate device based on material, sterility, intended use, and general characteristics, rather than new performance claims requiring extensive testing.

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and performance studies based on the provided text.

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