Search Results

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.

Ask a specific question about this device

Nobel Biocare's Procera Titanium Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Procera Titanium Abutments fit the following endosseous implants:

• AstraTech 3.5, 4.0, 4.5, 5.0 mm

• Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm

Nobel Biocare's Procera Titanium Abutment for AstraTech and Camlog Implant Systems 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 Titanium Abutment for AstraTech and Camlog Implant Systems is similar in design, intended use, and operation to the abutments cleared in predicate devices.

The provided text (K061478) is a 510(k) summary for a medical device called "Procera Titanium Abutment for AstraTech and Camlog Implant Systems." This document describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) submission process for this type of device typically relies on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics but no new questions of safety and effectiveness are raised. It does not generally involve a new clinical study with acceptance criteria in the same way an AI/ML device would.

Therefore, I cannot provide the requested information based on the provided text. The tables and study details you've asked for (such as sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) are typically associated with performance evaluations of AI/ML-driven devices, which this dental implant abutment is not.

The document essentially states that the device is similar in design, intended use, and operation to previously cleared abutments and is therefore substantially equivalent.

Ask a specific question about this device

Nobel Biocare's Multi-Unit Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Multi-Unit Abutments fit the following endosseous implants:

• AstraTech 3.5, 4.0, 4.5, 5.0 mm
• Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
• Ankylos 3.5, 4.5, 5.5, 7.0 mm

Nobel Biocare's Multi-Unit Abutment is an artificial tooth abutment designed to fit and function on the below endosseous implants:

• AstraTech 3.5, 4.0, 4.5, 5.0 mm -
• -Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
• . Ankylos 3.5, 4.5, 5.5, 7.0 mm
  The Multi-Unit Abutment is a prosthetic device that fits only the endosseous implants specified. The device has been developed for long-term, permanent use.
  Nobel Biocare's Multi-Unit Abutment is similar in design, intended use, and operation to the abultnents cleared in predicate devices.

The provided text is a 510(k) Summary for a dental abutment device. It outlines the device description, indications for use, and a letter from the FDA confirming substantial equivalence. However, it does not include information about acceptance criteria, detailed study results, sample sizes for test or training sets, expert qualifications, ground truth establishment, or any comparative effectiveness studies (MRMC) or standalone performance studies.

Therefore, I cannot provide the requested information from the given input. The document focuses on regulatory approval based on equivalence to predicate devices, rather than detailed performance study results with acceptance criteria.

Ask a specific question about this device