SIMDA Abutments

SIMDA Abutments are endosseous dental implant abutments intended for use with dental implants to support single or multiple tooth prostheses in partially or fully edentulous patients. The device consists of pre-milled blanks, Ti-Base abutments, multi-unit abutments, and multi-unit bases made of titanium alloy (Ti-6Al-4V ELI) that are designed by clinicians or labs and milled at SIMDA-validated milling centers.

The subject device and primary predicate (SIMDA Abutment K223663) share identical classification, product code (NHA), and material (Ti-6Al-4V ELI per ASTM F136). Minor differences exist in design parameters: the subject device's minimum wall thickness ranges from 0.32–0.71 mm versus the predicate's 0.4 mm, and gingival collar options differ slightly (3.8, 4.0, 4.5 mm for subject versus 3.8, 3.9, 4.0, 4.2, 4.3, 4.5, 5.2, 5.5, 5.8, 6.2 mm for predicate).

ISO 14801:2016 (Fatigue Test), ISO 17665-1:2006 and 17665-2:2009 (Steam Sterilization), ANSI/AAMI ST79:2010 (Sterilization), ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010 (Biocompatibility). Dimensional analysis and reverse engineering of implant-to-abutment connections were also performed.

The subject device is substantially equivalent to its primary predicate because both share the same intended use (prosthetic support for dental implants), identical classification and regulatory designation, same material composition, and comparable physical dimensions and design parameters. Non-clinical testing demonstrated fatigue performance and biocompatibility meeting applicable standards, and compatibility with multiple OEM implant systems was verified through dimensional analysis.