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NobelProcera Zirconia Implant Bridge (previously cleared per K202452) The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially edentulous jaws for the purpose of restoring chewing function.

TiUltra Implants and Xeal Abutments (previously cleared per K202344) NobelActive TiUltra NobelActive TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. Nobel Active Tilltra implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Nobel Active TiUltra 3.0 implants are indicated for single-unit restorations only. NobelReplace CC TiUltra NobelReplace CC TiUltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC Tilltra implants can be used in splinted or non-splications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied. NobelParallel CC TiUltra NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early of delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with

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This document is a 510(k) premarket notification decision letter from the FDA to Nobel Biocare AG regarding their Dental Implant Systems Portfolio - MR Conditional. It explicitly states that the letter covers indications for use and general controls, but does not contain information about acceptance criteria or performance studies for the device itself.

Therefore, I cannot provide the requested information for the following reasons:

1. Acceptance Criteria and Performance Data: The document is a regulatory clearance letter, not a clinical study report. It does not contain acceptance criteria for device performance, nor does it present any data from studies proving the device meets particular criteria. The letter confirms substantial equivalence to legally marketed predicate devices, which means the FDA has determined the device is as safe and effective as a previously cleared device, not that specific performance metrics were tested and met in a new study.
2. Study Details (Sample size, data provenance, experts, adjudication, MRMC, Standalone, Ground Truth, Training Set): Since no performance study data is included in this FDA 510(k) clearance letter, none of these details can be extracted. The document refers to various previously cleared predicate devices (e.g., K202452, K202344, K181869), but it doesn't describe the studies that led to their clearance.

In summary, the provided text does not contain the information necessary to describe acceptance criteria or a study proving the device meets those criteria.

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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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