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8plant Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Implant bodies with a diameter of 5mm or more are intended to be used in the molar region.

8plant Implant System consists of SF Fixtures, Cover Screw, Abutment, and Abutment Screw.

1. 8plant Implant System (SF Fixtures and Cover Screw)
   This titanium dental implant features a SLA (Sandblasted with Large-grit and Acid-etched) surface with the alveolar bone and is designed to support single or multiple-unit restorations in partially or fully edentulous patients. It is secured to the upper structure using an internal hex fastening system.
2. 8plant Abutment System (Abutment and Abutment Screw)
   8plant Abutment System is compatible with the SF Fixtures. 8plant Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. The 8plant Abutment System consists of the following; Healing Abutment, Rigid Abutment, Locator Abutment, Transfer Abutment, Angled Abutment, Temporary Abutment, Abutment Screw.

The provided document describes a 510(k) premarket notification for the "8plant Implant System." This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria with reported device performance.

Therefore, the requested information for acceptance criteria and a study proving the device meets them, including specific details like sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, and training set sample size/ground truth establishment, is not available in this document.

The document primarily highlights:

• Substantial Equivalence Comparison: The core of the submission is a comparison of the subject device (8plant Implant System) to a primary predicate device (ZENEX Implant System) and several reference devices. This comparison is presented in tables detailing similarities and differences in intended use, structure, dimensions, material, surface treatment, and sterilization methods for various components (fixture, cover screw, abutments, abutment screw).
• Non-clinical Testing: The document lists bench tests conducted to "verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device." These tests were performed to ensure compliance with standards relevant to dental implants:
  • Mechanical Performance: Fatigue testing (ISO 14801:2016).
  • Surface Analysis: Utilizing EDS and SEM evaluations for SLA treated surfaces.
  • Sterilization, Shelf-life, and Packaging: Gamma sterilization validation (ISO 11137 series), End User Sterilization Validation (ISO 11138-1, ISO 17665 series, ISO 11737 series), and real-time aging tests (ASTM F88, ASTM F1929).
  • MR Environment Condition: Non-clinical worst-case MR review based on scientific rationale and published literature.
  • Bacterial Endotoxin: Testing to ensure endotoxin levels are below 0.5 EU/mL (USP ).
  • Biocompatibility: Evaluations according to ISO 10993-1 and ISO 10993-12.

The document concludes that the "results of the below tests have met the standards and demonstrated the substantial equivalence with the predicate device." However, it does not provide specific numerical acceptance criteria or detailed performance data from these tests. It simply states that the device 'met the standards' or 'demonstrated substantial equivalence.'

Without a dedicated clinical study or further non-clinical performance data with explicit acceptance criteria and corresponding results, it's impossible to fill out the table and provide the in-depth study information requested.

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