(670 days)
"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:
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.