# K092555: Uno Narrow Implant

- Pathway: 510(k) (Traditional)
- Applicant: Mis Implants Technologies, Ltd.
- Decided: Jan 5, 2010 after 138 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: 1 generation back to K080396 (2008). 1 ancestor in all.
36 later devices descend from it; 4 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080396: Osseospeed Narrow, Astra Tech AB (2008) Summary page 2.

## Most influential descendants
- K132125: A.B. Dental Devices Dental Implants System (2014), 25 descendants of its own
- K140440: Noris Medical Dental Implants System (2014), 14 descendants of its own
- K130462: Paltop Narrow Implant, Paltop Short Implant (2013), 8 descendants of its own
- K151909: Noris Medical Zygomatic Dental Implant System (2016), 7 descendants of its own
- K210117: Paltop Narrow Implant (2021), 5 descendants of its own

## Indications for use
The UNO Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by adjacent teeth and roots, 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 03.0 mm implants adjacent to one another. The UNO Narrow Implant is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

Source page: https://510kreport.com/device/K092555
Methodology: https://510kreport.com/methodology