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NobelZygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arch to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Nobel Biocare's NobelZygoma 0° implants are threaded, root-form titanium dental implants intended to be integrated in the Zygomaticus bone to support prosthetic devices, such as artificial teeth, in order to restore chewing function. The NobelZygoma 0° implants typically pierces the oral mucosa in the premolar region and passes through the sinus along the lateral wall of the maxilla. Depending on the contour of the lateral maxillary wall, the mid-portion of the implant may also pass lateral to the lateral wall. The NobelZygoma 0° implants are available in lengths between 30 and 50 mm and have a 4.5 mm external hex connection. They are made of commercially pure titanium and have the Nobel Biocare TiUnite surface treatment.

Nobel Biocare's NobelZygoma 0° abutments are implant abutments intended to be used with the NobelZygoma 0° implant only. The NobelZygoma 0° abutments are used to accommodate the total angle of the implant – abutment joint. This is necessary since the subject implant has a flat platform rather than the 45° platform of the predicate device implants. The NobelZygoma 0° abutments are available in lengths between 6 and 10 mm and with angle of 45° or 60°. They contain the external hex connection and are made of a titanium alloy without any additional coating.

The Temporary Coping Multi-Unit and Temporary Coping Plastic Multi-unit are premanufactured dental abutment directly connected to the Multi-unit abutment. It is used as a temporary aid in prosthetic rehabilitation until the final restoration is attached. Maximum intraoral use is 180-days.

This document does not describe an AI/ML device and therefore does not contain the information requested regarding acceptance criteria and a study proving a device meets them for such a device.

The provided text is a 510(k) premarket notification for a medical device called "NobelZygoma 0°", which is an endosseous dental implant. The notification focuses on establishing substantial equivalence to a predicate device ("NobelZygoma 45°") through non-clinical performance data (bench testing) and material/design comparisons, not on evaluating the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and reported device performance (for an AI/ML device).
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (for an AI/ML device).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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