Search Results

Camlog Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. Camlog Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

The Camlog Implant System includes various sizes of threaded root-form dental implants and abutments intended to support prosthetic restorations in edentulous or partially edentulous patients. The implants can be placed immediately following extraction or after a healing period. If good primary stability is reached the implants may be immediately loaded. The complete system includes a variety of laboratory (burnout) copings, impression copings, analogs and other components intended to facilitate the preparation of prosthetic restorations.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for the CAMLOG Implant System, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting performance study results against predefined acceptance criteria.

The 510(k) summary states:

• "The components of the CAMLOG Implant System, including the modified implants and abutments, have the same basic design as the predicate devices."
• It highlights similarities such as "same intended use," "same operating principle," "same basic design," "same materials," and "similar packaging and is sterilized using the same materials and processes."

This type of submission relies on demonstrating that the new device is as safe and effective as an already cleared device, rather than on new performance studies with acceptance criteria. Therefore, I cannot provide the requested information.

Ask a specific question about this device