Surcam Dental Implant System

The Surcam Dental Implant System is an endosseous dental implant system used to surgically place implants in the upper or lower jaw bone to support prosthetic devices such as artificial teeth and restore chewing function. The system supports single and multiple-unit restorations and can be used for immediate loading when good primary stability is achieved. The system includes implants, abutments, cover screws, and healing caps in both conical and internal hex connection types.

The Surcam system consists of titanium alloy (ASTM F136 Ti6AL4V ELI) implants available in conical and internal hex connections with implant diameters ranging from 3.3mm to 6.0mm and lengths from 8mm to 18mm. It offers two conical platforms (NP and RP) and includes multiple abutment designs with angulations up to 25°, healing caps, multi-unit abutments, and various screws. The implants are alumina blasted and acid etched with demonstrated post-surface treatment cleanliness.

Dynamic fatigue testing per ISO 14801; surface cleanliness analysis; sterilization validation per ISO 11137-1, 11137-2, and ISO 17665-1 and -2; endotoxin testing per USP 161; shelf life and package integrity testing per ASTM F1980, ASTM F1929, ASTM 2338, ASTM D3078, and ISO 11607-1; MRI safety evaluation based on published literature regarding magnetically induced displacement force and torque.

Surcam is substantially equivalent to Surgikor (predicate K182615) because both devices share identical indications for use, identical material composition (Ti6AL4V ELI), and the same connection types (internal hex and conical). Minor design differences in implant and angled abutment geometry were addressed by demonstrating both devices achieved adequate fatigue performance under ISO 14801. Larger diameter implants and additional abutment designs not present in the predicate were supported using reference devices (Cortex, OsseOne, Dentsply Sirona, AB Dental, Osstem) that share the same materials, similar indications, and identical connection interfaces, all demonstrating equivalent performance characteristics.