(82 days)
Nobel Biocare's Procera Zirconia Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Procera Zirconia Abutments fit the following endosseous implants: Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
Nobel Biocare's Procera Zirconia Abutment for Camlog Implant System is fabricated to the exact shape, size, and specifications determined in the design process in order to achieve a personalized device that fits precisely, and properly functions, according to each patient's individual needs.
Nobel Biocare's Procera Zirconia Abutment for Camlog Implant System is similar in design, intended use, and operation to the abutments cleared in predicate devices.
The provided text describes a 510(k) summary for the Procera Zirconia Abutment for Camlog Implant System. It focuses on device description, intended use, and substantial equivalence to predicate devices, but does not contain any information about acceptance criteria, study data, sample sizes, ground truth establishment, or expert involvement for assessing device performance.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study design, and performance metrics as this information is not present in the provided document.
This particular document is a regulatory submission summary, indicating the device has been deemed substantially equivalent to existing devices, which means it meets the regulatory requirements for marketing, but it does not detail the specific performance testing data that might be associated with such a determination.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)