INNO SLA Mini Plus® Implant System

The INNO SLA Mini Plus® Implant System is a one-piece endosseous dental implant made of commercially pure titanium with SLA surface treatment. It has two types: a Cemented Type for temporary support of missing maxillary lateral or mandibular central/lateral incisors during healing of permanent implants, and a Ball Type for temporary overdenture support (max 180 days), both indicated for immediate loading when primary stability is achieved.

The device differs from predicate devices primarily in surface treatment (SLA vs. RBM), diameter range (2.5/3.0 mm vs. 2.0–3.5 mm), and length options (10.0/12.0/14.0 mm vs. broader ranges). Companion components include protection caps (4.05 mm diameter, 6.8 mm length, POM material) and ball attachments with nylon prosthetic retention (3.4 mm abutment diameter, Ti-6Al-4V ELI abutment).

ISO 17665-1 and ISO 17665-2 (sterilization validation); ANSI/AAMI ST72:2011 (bacterial endotoxins testing via LAL gel-clot technique); ASTM F2052, F2213, F2182, and F2119 (MRI safety testing for magnetic displacement force, torque, RF heating, and image artifact).

The Cemented Type shares identical intended use, design concept, and principle of operation with the S-Mini Implant System (K112540) predicate, with size ranges that fall within predicate scope. The Ball Type similarly matches the S-Mini predicate for overdenture support. Although surface treatment differs (SLA vs. RBM), biocompatibility and chemical analysis testing demonstrated the difference does not raise substantial equivalence questions. Protection caps and ball attachments have the same intended use, raw materials, and technical characteristics as predicate components, supported by biocompatibility testing.