Alpha Dent Implants Dental Implants System

The Alpha Dent Implants Dental Implants System is intended for surgical placement in the upper or lower jaw to support crowns, bridges, or dentures in patients without teeth. It restores chewing function and can support single or multiple teeth. The system is indicated for immediate loading when good primary stability is achieved with appropriate occlusal loading.

The implants are tapered, threaded root-form implants manufactured from Grade 4 commercially pure titanium (Ti CP4) with a sandblasted, large-grit, acid-etched (SLA) surface treatment. They feature a conical connection with a 2.1 mm hexagon platform and come in diameters from 3.3–6.0 mm and lengths from 8–13 mm. The implants are packaged wet in isotonic sodium chloride (0.9% NaCl) solution within a titanium protective sleeve.

ISO 14801:2016 (dynamic fatigue testing), ISO 10993-1:2018 (biocompatibility), ISO 10993-5:2009 (cytotoxicity), ASTM F67-13 and F136-13 (titanium material specifications), ASTM F-1980 (accelerated aging), ANSI/AAMI/ISO 11137-1 and EN ISO 11137-2 (sterilization validation), ISO 11607-1:2019 (packaging), USP<85> and ANSI/AAMI ST72 (pyrogenicity via LAL method).

Substantial equivalence is based on identical intended use, device classification, implant/abutment connection design, platform diameter, and surface treatment (SLA) compared to the primary predicate K210499 (Alpha Dent Implants). Although the subject devices use Ti Grade 4 instead of Grade 5, mechanical testing per ISO 14801 on worst-case scenarios (25° abutment angulation, 3.3 mm diameter) confirmed equivalent performance. Biocompatibility testing per ISO 10993-1 for the Ti Grade 4 material, supplemented by hydrophilicity and cytotoxicity studies on aged implants, demonstrated safety equivalent to the predicate. The wet packaging in NaCl 0.9%, gamma irradiation sterilization, and support for immediate loading further establish substantial equivalence.