# K080162: Uno - One Piece Screw-Type Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Mis Implants Technologies, Ltd.
- Decided: Apr 22, 2008 after 90 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 K052997 (2006). 1 ancestor in all.
39 later devices descend from it; 4 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052997: Zimmer Dental One-Piece Implant, Zimmer Dental, Inc. (2006) Summary page 2.

## Most influential descendants
- K112440: AB Dental Devices Implants and Accessories (2012), 36 descendants of its own
- 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
- K151909: Noris Medical Zygomatic Dental Implant System (2016), 7 descendants of its own
- K140728: Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece Implant, Dental Abutments and PR (2014), 6 descendants of its own

## Indications for use
The Uno - One Piece Screw-Type 3.0 mm Dental 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, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.0 mm Dental Implant is made of one piece solid material comprised of the implant and abutment combination. Mandibular central and lateral incisors must be splinted if using two or more 3.0 mm implants adjacent to one another. The Uno implants are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02. The Uno - One Piece Screw-Type 3.5 mm Dental Implants are indicated for use in surgical and restorative applications for placement in the premolar, cuspid and incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.5 mm Dental Implants are made of one piece solid material comprised of the implant and abutment combination. The Uno implants are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02.

Source page: https://510kreport.com/device/K080162
Methodology: https://510kreport.com/methodology