Dental Implants and Abutments

Ditron's Dental Implants and Abutments are endosseous implants and associated prosthetic components designed for surgical placement in the upper or lower jaw to support artificial teeth and restore chewing function in fully or partially edentulous patients. The devices include two-stage implants (MPI, ULT, API, CPI, MPC, APC, CPC, UPC) and one-stage implants (OPI, TPI), along with various abutment types for temporary or long-term use.

The new Conical Connection (CC) implants feature a Morse taper interface (16° conical connection) with color anodization for aesthetics, whereas the predicate Internal Hex implants use a hexagonal connection. The CC implants share identical bone-contacting surface design, drilling protocol, thread design, and bone interface with their Internal Hex counterparts. Both are manufactured from Ti-6Al-4V-ELI, machined, sand-blasted, acid-etched, sterilized by gamma irradiation, and have 5-year shelf lives. New abutment types include CC Healing Caps, CC Cement-Retained Abutments, CC Single/Multi-Unit Abutments, CC Temporary Titanium and PEEK Abutments, CC Liberator Overdenture Abutments (with TiN coating), and SRA Titanium Coping Abutments.

ISO 10993-1, 10993-5, and 10993-11 (biocompatibility); ISO 11137-2 and AAMI TIR33 (gamma sterilization validation); ISO 17665 and ANSI AAMI ST79 (steam sterilization); ISO 14801 and FDA Guidance (fatigue testing); ASTM F1160-14, F1147-05, and F1978-22 (TiN coating evaluation); ISO 11607-1 (shelf life and package integrity).

The subject CC implants are substantially equivalent because they possess identical intended use, surface designs, drilling protocols, thread configurations, and bone interface characteristics to the predicate Internal Hex implants; the only difference is the implant-to-abutment connection geometry (Morse taper versus hexagon), which does not affect safety or efficacy. New abutments are equivalent to predicates with similar or identical technological characteristics, materials, sterilization methods, and indications for use. Comprehensive non-clinical testing (biocompatibility, sterilization validation, fatigue testing) confirms mechanical and biological equivalence, and TiN coating evaluation met all acceptance criteria per ASTM standards.