DAND Dental Implant System

The DAND 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 devices such as artificial teeth. The system restores patient esthetics and chewing function through single or multiple unit restorations on splinted or non-splinted applications, with some implants (Charanga, Bolero, DACA) supporting immediate loading when primary stability is achieved.

The system comprises two internal hex implant designs (Charanga and Bolero) and one conical design (DACA), all made from Ti-6AL-4V ELI with grit-blasted and acid-etched (SLA) surfaces. Implants range from 3.3–6.0 mm diameter and 8–16 mm length. The device includes multiple abutment types (straight, angled, shouldered, ball attachments, retentor attachments) with interface angles up to 30° and various healing caps and cover screws compatible with internal hex and conical platforms.

ISO 14801 (dynamic fatigue testing), ISO 10993 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-23:2021 (irritation), ISO 17665-1 (steam sterilization validation), ANSI/AAMI ST72:2019 and USP <161> (bacterial endotoxin), ISO 11137-2 (gamma irradiation), ASTM D999-08, ASTM F3039-13, ASTM D5276-98 (package testing), ASTM F1929-12, ASTM F1980-07 (shelf life), and FDA guidance on MRI safety.

DAND is substantially equivalent to TOV Dental Implant System (K240837) because both systems share identical indications for use (single/multiple endosseous restorations with immediate or delayed loading), the same material composition (Ti-6AL-4V ELI with SLA surface treatment), equivalent internal hex and conical interface designs, comparable abutment portfolios with matching dimensions and angulations, and similar ISO 14801 fatigue performance demonstrating sufficient run-out loads. The identical design features, material specifications, and biocompatibility/performance test results establish functional and performance equivalence despite minor nomenclature differences (Charanga/Bolero/DACA vs. Maer/Ragil/TCX).