510(k) Premarket Notification
Subject Device Predicate Devices Name AIDI Dental Implant System (AIDI Internal Fixture and Abutments) (K101755) IDI Implant Systems (IDI Internal Fitures and Abutments) (K081806) Material Titanium ASTM F67 Grade 4 or ASTM F-136 6AL4V ELI Titanium ASTM F67 Grade 4 or ASTM F-136 6AL4V ELI Coronal Design Tapered Coronal Design No Internal Screw Thread Yes Yes Implant Body Design Tapered Tapered Implant Body Diameter (mm) 3.2, 3.7, 4.7, 5.4 3.7, 4.7, 5.4, 6.4 Length (mm) 8.8~16.0 8.8~16.0 One-Stage Surgical Procedures Yes No Two-Stages Surgical Procedures Yes Yes Implant/ Abutment Interface Hexagonal Interlocking Hex-Lobe Interlocking Surface Treatment Soluable Blast Media (Tricalcium Phosphate/ Hydroxyapatite, conform to ASTM F1185-03) Resorbable media Blasting (Tricalcium Phosphate/ Hydroxyapatite, conform to ASTM F1185-03) Gamma Sterilized Yes Yes Attachments Screw-retained restoration system Screw-retained restoration system
