Search Results

The Implant for dental purposes, used to replace missing dental organs (teeth). The Implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the Implant receives a post, which has a stem, and is adapted to carry dental suprastructures (false teeth).

The BASIC Dental Implant is an endosseous dental implant.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.

Specifically:

1. Acceptance Criteria and Reported Device Performance: The document explicitly states "Performance Data: None" and "Results of Clinical Study: None." Therefore, no table can be created.
2. Sample Size and Data Provenance (Test Set): Not applicable, as no study results are reported.
3. Number and Qualifications of Experts (Ground Truth - Test Set): Not applicable.
4. Adjudication Method (Test Set): Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable, as no study is detailed.
6. Standalone Performance Study: Not applicable.
7. Type of Ground Truth Used: Not applicable.
8. Sample Size for Training Set: Not applicable.
9. How Ground Truth for Training Set was Established: Not applicable.

The document is a 510(k) summary for the BASIC Dental Implant System Implant. It focuses on demonstrating substantial equivalence to a legally marketed predicate device (BASIC Dental Implant System, K960868), which allowed it to be marketed without new clinical performance data. The FDA letter confirms the substantial equivalence determination.

Ask a specific question about this device