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Calcitek Dental Implant Systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm.

These Class III dental implants are supplied sterile, ready for placement by a licensed dontist.

The provided text is a 510(k) summary for Calcitek HA-Coated Endosseous Dental Implants from 1997. It describes the device and its intended use, and states that it is substantially equivalent to a predicate device. However, this document does not contain the information requested regarding acceptance criteria and a study proving device performance against those criteria.

Specifically, the document focuses on:

• Company and contact information.
• Classification and trade names.
• Intended Use statement.
• Description of the device.
• Technological characteristics (noting no change in design, and same materials except for an enhanced HA coating composition).
• Comparison Analysis emphasizing the identical overall design to predicate devices and the change in HA coating composition.
• FDA correspondence affirming substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, ground truth establishment, or details about comparative effectiveness studies, as this information is not present in the provided text. The document's purpose is to establish substantial equivalence for regulatory approval, not to present a detailed clinical or performance study report.

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