BLUEDIAMOND IMPLANT

The BLUEDIAMOND IMPLANT is a dental implant body made of CP Ti Grade 4 with SLA surface treatment, designed to be surgically placed in the maxillary or mandibular molar areas to support dental restorations (crowns, bridges, dentures) in partially or fully edentulous patients. It supports both delayed loading and immediate loading when good primary stability is achieved.

The device features an internal octa implant-to-abutment connection, tapered body design with 0.8mm thread pitch, and comes in multiple diameter and length configurations with normal and deep thread options. Key differences from the predicate include slightly different widest thread diameter, total length, threaded length, implanted length, and gingival cuff height ranges, though all dimensions fall within the ranges established by predicate and reference devices.

ISO 10993-1 (biocompatibility), ISO 11137 (sterilization validation), ASTM F1980 (shelf life accelerated aging), ISO 14801 (fatigue testing), USP 39 <85> (endotoxin testing), and FDA guidance on Class II special controls for root-form endosseous dental implants.

The device is substantially equivalent because it shares the same material (CP Ti Grade 4), surface treatment (SLA), design features (tapered body, 0.8mm thread pitch), implant-to-abutment connection type (internal octa), sterilization method, and indication for use as the predicate device. Although dimensional specifications differ slightly, all subject device dimensions fall within the ranges of predicate and reference devices, and fatigue testing per ISO 14801 confirmed the device meets performance criteria, demonstrating that dimensional variations do not affect fundamental safety and effectiveness.