# K250176: DAND Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: D.A.N.D. Metal Industries North, Ltd.
- Decided: Apr 21, 2025 after 89 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K894595 (1990). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240837: TOV Dental Implant System, Rdj Tov Implant, Ltd. (2024) Summary page 8.

## Indications for use
The DAND Dental Implant System are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient’s esthetics and chewing function. Implants are intended for single or multipl unit restorations on splinted or non-splinted applications. Charanga, Bolero and DACA are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. Bolero 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another.

Source page: https://510kreport.com/device/K250176
Methodology: https://510kreport.com/methodology