MBA Biotech Implant System

The MBA Biotech Implant System is a two-stage endosseous screw-type dental implant with internal hexagonal connection, used to replace missing teeth in partially or fully edentulous patients. It supports single or multiple unit restorations (cemented, screw-retained, or overdenture) and is intended for delayed loading, with a wide fixture system for molar regions.

The fixture is made of pure titanium (ASTM F67) with sandblasted, large-grit, acid-etched (SLA) surface treatment, provided sterile. Abutments (cemented, angled) and screws are fabricated from Ti-6Al-4V (ASTM F136), provided non-sterile. Dimensions range from 3.75–6.75 mm diameter and 7–15 mm length for fixtures, with multiple abutment configurations at 0°, 15°, 17°, and 25° angulation.

ISO 14801:2016 (fatigue testing), ANSI/AAMI ST79, ISO 17665-1/-2, ISO 11737-1/-2, ISO 11138-1 (end-user sterilization validation), ISO 11137-1/-2/-3 (fixture sterilization), ASTM F1980 (shelf-life), ISO 10993 series (biocompatibility), ANSI/AAMI ST72:2011 (bacterial endotoxin), and FDA MR Environment guidance (MRI safety).

The subject device and predicate (K211090 IZEN Implant System) share identical indications for use, general design as two-stage endosseous screws with internal hex connection, same materials and material grades, identical surface treatment (SLA), same sterilization method (gamma radiation), and overlapping dimensional ranges. Minor differences in coating presence and length do not impact fundamental technology. Both are manufactured by the same entity with identical manufacturing processes, materials, sterilization, and packaging; therefore biocompatibility and sterilization validation data are leveraged directly from the predicate.