# K221315: UNIdental Symphony Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Unidental Co., Ltd.
- Decided: Oct 25, 2023 after 537 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: 17 generations back to K960026 (1996). 164 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 166 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160965: SuperLine, Dentium Co., Ltd. (2017) Summary page 5.
- K172640: Dentium Implantium & SuperLine Prosthetics, Dentium Co., Ltd. (2018) Summary page 5.
- K200586: Straumann TLX Implant System, Institut Straumann AG (2020) Summary page 5.
- K161416: Multi-unit Abutment Plus, Nobel Biocare AB (2017) Summary page 6.
- K052823: Implantium Abutments, Dentium, Inc. (2006) Summary page 6.

## Most influential descendants
- K262207: Cemented Plus Abutment (2026), 0 descendants of its own

## Indications for use
The UNIdental Symphony Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The UNIdental Symphony Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

Source page: https://510kreport.com/device/K221315
Methodology: https://510kreport.com/methodology