# K180598: UNIQA Dental Implants System

- Pathway: 510(k) (Traditional)
- Applicant: Uniqa Dental, Ltd.
- Decided: Aug 8, 2018 after 154 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: 5 generations back to K925765 (1993). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040807: Mis Dental Implant System, Mis - Implant Technologies, Ltd. (2004) Summary page 4.

## Most influential descendants
- K251188: UNIQA® Dental Implants System (2026), 0 descendants of its own

## Indications for use
UNIQA® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. UNIQA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. UNIQA Conical Connection Implants: #UCI & #UC7 are to be used only with straight abutments. Conical Mini implants (d3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

Source page: https://510kreport.com/device/K180598
Methodology: https://510kreport.com/methodology