DIMPLO Implant System

The DIMPLO Implant System is a dental implant system consisting of fixtures (implant bodies made of titanium Grade 4), abutments, and attachments designed for use in the maxilla or mandible of partially or fully edentulous patients. It supports single or multiple-unit restorations including cemented, screw-retained, or overdenture restorations, and may be used for immediate loading when good primary stability is achieved.

The fixtures are made of unalloyed titanium (Grade 4, ASTM F67) with SLA surface treatment, available in diameters ranging from 3.3 to 6.8 mm and lengths from 8 to 15 mm, using internal hex connection interface. Abutments are made of Ti-6Al-4V ELI (ASTM F136) or include zirconia superstructures with titanium bases. All components are either gamma-sterilized (fixtures) or provided non-sterile for user sterilization, with 5-year shelf life.

ISO 11137-1 and ISO 11137-2 (sterilization validation), ASTM F1980 (shelf-life testing), ANSI/AAMI ST72 (endotoxin testing), ISO 17665-1, ISO 17665-2, and ANSI/AAMI ST79 (steam sterilization), ISO 10993-5, 10993-10, and 10993-23 (biocompatibility), ISO 14801:2016 (mechanical testing), and FDA guidance on MRI safety.

The subject device has the same intended use, materials, abutment-implant interface (internal hex), surface treatment (SLA), sterilization method (gamma or steam), and shelf life as the primary and reference predicate devices. Implant diameters and lengths are within or comparable to those of predicate devices. Any differences in design do not raise new questions regarding safety or effectiveness.