BIORES Dental Implant System

The BIORES Dental Implant System is an endosseous dental implant indicated for surgical placement in the upper and lower jaw to support single or multiple-unit prosthetic restorations and restore chewing function. Implants can be placed using conventional two-stage surgery with transmucosal healing options or single-stage surgery for immediate loading when primary stability is achieved. The system includes the implant, abutments, and accessories made from titanium materials.

The implant is made of Titanium Grade 4 (ASTM F67) with a sandblasted and acid-etched (SLA) surface, tapered design with internal hex connection, diameters ranging 3.7–6.0 mm, and lengths 7–14.4 mm. It is gamma-sterilized with 8-year shelf life. Abutments and accessories are made of Ti-6Al-4V ELI (ASTM F136) and include bonding abutment, healing abutment, central screw, and cover screw, with 5-year shelf life for most components.

ISO 10993-1 and ISO 10993-5 (biocompatibility); ISO 11137-1 and ISO 11137-2 (irradiation sterilization); ISO 14801 (fatigue testing); ANSI/AAMI ST72 (endotoxin testing); ANSI/AAMI/ISO 17665-1 and 17665-2 (steam sterilization reprocessing); ASTM F67 and ASTM F136 (material specifications).

The subject device has identical intended use, material composition, thread type, placement type, and sterilization method as the primary predicate (K171027, Dentis Dental Implant System). Differences in design variants, dimensions, and surface treatment (SLA vs. RBM) are within the known range of predicate devices or covered by reference predicates. Performance testing demonstrates biocompatibility, sterilization efficacy, shelf-life stability, and fatigue resistance equivalent to predicate devices.