# K251188: UNIQA® Dental Implants System

- Pathway: 510(k) (Traditional)
- Applicant: Uniqa Dental, Ltd.
- Decided: Jun 25, 2026 after 434 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: 6 generations back to K925765 (1993). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180598: UNIQA Dental Implants System, Uniqa Dental, Ltd. (2018) Summary page 6.

## Indications for use
UNIQA Dental® 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® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Conical Mini implants (&3.3mm) 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/K251188
Methodology: https://510kreport.com/methodology