Quickdent Dental Implant System

The Quickdent Dental Implant System is a set of endosseous (bone-anchored) dental implants designed to be surgically placed in the upper or lower jaw to support prosthetic teeth and restore chewing function and aesthetics. The system includes multiple implant designs (internal hex and conical), abutments, healing caps, and accessories for single or multiple tooth restorations, with some implants approved for immediate loading when primary stability is achieved.

The device consists of three internal hex implant designs (Ossi Classic IH, Trabecos IH, Korticale TPR IH), two conical implant designs (Acti Fix CC, Kortifix Pro CC), and one one-piece implant (Korticale SP), all made from Ti-6AL-4V ELI with grit-blasted and acid-etched surfaces. It includes numerous abutment types (straight, angled, shouldered, multi-unit) with internal hex or conical connections, healing caps in various diameters and heights, and attachment systems (ball attachments, Quickloc/Quicksnap locator attachments) allowing 14–20° implant divergence.

ISO 14801 (dynamic fatigue testing), ISO 10993 (cytotoxicity, skin sensitization, irritation testing), ISO 17665-1 (steam sterilization validation), ISO 11137-2 (gamma irradiation validation), ANSI/AAMI ST72:2019 (bacterial endotoxin testing), ASTM D999-08, ASTM F3039-13, ASTM D5276-98, ASTM F1929-12, and ASTM F1980-07 (package and shelf-life testing).

Quickdent is substantially equivalent to TOV Dental Implant System (K240837) because both systems have identical indications for use, identical material composition (Ti-6AL-4V ELI), identical surface treatment (SLA), and equivalent connection types (internal hex and conical). Both devices underwent the same categories of performance testing (ISO 14801 fatigue, biocompatibility, sterilization validation) with comparable results; minor design differences in implant geometry are addressed by the reference predicate (Zimmer One Piece K052997), establishing equivalence across the full product line.