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The Nobel Biocare Centric Post is a support component indicated for use as an alignment post to center an abutment and as a seal to prohibit fluids from seeping into the implant interior.

The Nobel Biocare Centric Post is a component within the implant system, which is intended for use in restoring the chewing function of fully edentulous and/or partially edentulous patients.

The Nobel Biocare Centric Post is a support component indicated for use as an alignment post to center a temporary abutment and act as a seal to prohibit fluids from seeping into the implant interior during temporization.

The Nobel Biocare Centric Post is a component within the implant system, which is intended for use in restoring the chewing function of fully edentulous and/or partially edentulous patients.

Nobel Biocare's Centric Post is a hollow, accessory component designed to enhance the performance of the implant/abutment system by ensuring proper alignment between an abutment and an endosseous implant, while additionally acting as a seal that prevents fluids from seeping into the implant interior.

The Nobel Biocare Centric Post does not contact any mucous membranes in the oral cavity because it rests inside the implant/abutment interface. The Centric Post can only be used as part of the implant system, not on its own. It is designed to remain inside the implant/abutment interface for as long as the implant remains in the patient's mouth.

These attributes of the Nobel Biocare Centric Post enhance the performance of the implant/abutment system, such as the Nobel Perfect Implant System, and make the component desirable for use in fabricating both final restorations and temporary restorations.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Nobel Biocare Centric Post. This type of regulatory submission in the US is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study with defined performance metrics as in a de novo or PMA submission for novel devices.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study to prove the device meets these criteria in the context of device performance, as it is focused on demonstrating substantial equivalence. It does not include:

1. A table of acceptance criteria and the reported device performance: This document focuses on demonstrating that the Nobel Biocare Centric Post is substantially equivalent to existing legally marketed devices (Replace® Scalloped Margin Implant System and Nobel Perfect Implant System) based on its design, intended use, and materials, rather than presenting a performance study against predefined acceptance criteria.
2. Sample size used for the test set and the data provenance: No performance testing data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth or expert evaluation is mentioned for performance assessment.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone performance (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily describes the device, its indications for use, and identifies predicate devices for the purpose of demonstrating substantial equivalence for 510(k) clearance.

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