# K011574: Uniplant Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Universal Implant Systems, Inc.
- Decided: Sep 28, 2001 after 129 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: 2 generations back to K900179 (1991). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923889: O Butment ES Implant, O Co., Inc. (1994) Summary page 3.
- K950066: Dental Implant Endosseous, O Co., Inc. (1995) Summary page 3.
- K961665: O Butment ET Implant, O Co., Inc. (1996) Summary page 3.
- K973926: O Butment HS Implant, O Co., Inc. (1998) Summary page 3.
- K962845: Replace HA Coated Implants, Steri-Oss, Inc. (1996) Summary page 3.
- K974401: 4.0MM Simpler One Threaded Dental Implant, Vancouver Implant Resources, Inc. (1998) Summary page 3.
- K974402: 3.25 MM Simpler One Threaded Dental Implant, Vancouver Implant Resources, Inc. (1998) Summary page 3.
- K974856: 3.25MM Simpler Threaded Dental Implant, Vancouver Implant Resources, Inc. (1998) Summary page 3.
- K974857: 4.0MM Simpler Threaded Dental Implant, Vancouver Implant Resources, Inc. (1998) Summary page 3.

## Indications for use
Intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.

Source page: https://510kreport.com/device/K011574
Methodology: https://510kreport.com/methodology