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"BoniPlus" Dental G-Mesh System is the non-absorbable membrane that is made of titanium metal to stabilize and support bone grafts in dento-alveolar bony defect sites.

The "BoniPlus" Dental G-Mesh System is a non-absorbable titanium screen made of pure Titanium (ASTM F-67), that helps in bone neoformation. They come in many different lengths, widths and thicknesses.

This document describes the "BoniPlus" Dental G-Mesh System, a non-absorbable titanium membrane designed to stabilize and support bone grafts in dento-alveolar bony defect sites. A 510(k) submission was made to the FDA to demonstrate its substantial equivalence to previously cleared predicate and reference devices.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are established through a series of non-clinical tests, and the device's performance is reported to meet these requirements, thus affirming its substantial equivalence to existing devices. The table below summarizes these criteria and the reported performance.

| Test Category | Acceptance Criteria/Requirement Description of Device Performance |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization | Compliance with ISO 11137-1, ISO 11137-2, ISO 11737-1, and ISO 11737-2 for gamma sterilization. | Sterilization verification successfully conducted according to the specified ISO standards for gamma sterilization. |
| Shelf Life | Compliance with ASTM F1980, ASTM F1929, ASTM F88/F88M, ASTM D882, BS EN 868-5, and ASTM F1140/F1140M for tensile, dye penetration, burst, and creep tests. | Shelf life determined to be 3 years based on successful completion of tensile test, dye penetration test, burst test, and creep test conforming to the listed ASTM and BS EN standards. |
| Biocompatibility | Compliance with ISO 10993-1, ANSI/AAMI/ISO 10993-5, ISO 10993-10, ISO 10993-2, ANSI/AAMI/ISO 10993-12, USP , and USP for in vitro cytotoxicity, sensitization, intracutaneous reactivity, and pyrogenicity. Pyrogen limit specification for endotoxin level set at 0.01 EU/device. | Biocompatibility tests (in vitro cytotoxicity, sensitization, intracutaneous reactivity, and pyrogenicity) were performed successfully according to the specified ISO, ANSI/AAMI/ISO, and USP standards. Endotoxin levels reported as:

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