# K083670: Universal, Aesthetica, Natea, Natura

- Pathway: 510(k) (Traditional)
- Applicant: Euroteknika
- Decided: Jul 23, 2009 after 224 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: 3 generations back to K931767 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040643: Branemark Integration Dental Implant and Accessories, Branemark Integration AB (2004) Summary page 1.
- K032140: 5.0 X 5MM Endopore Endosseous Dental Implant System, Innova Life Sciences Corp. (2003) Summary page 1.
- K024111: Astra Tech Implants-Dental System Fixture Osseospeed, Astra Tech, Inc. (2003) Summary page 1.
- K011245: Advent Implant System, Swiss Plus Implant System, Sulzer Dental, Inc. (2001) Summary page 1.

## Indications for use
The device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients. The device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients. The device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients. The device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients.

Source page: https://510kreport.com/device/K083670
Methodology: https://510kreport.com/methodology