# K053354: Intermezzo Plus Fixture

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Co., Ltd.
- Decided: Apr 13, 2006 after 132 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 K051018 (2005). 1 ancestor in all.
45 later devices descend from it; 2 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051018: Intermezzo Implant Systems, Megagen Co., Ltd. (2005) Summary page 1.

## Most influential descendants
- K072959: MS System (Denture) (2008), 43 descendants of its own
- K080594: MS System (Narrow Ridge) (2008), 42 descendants of its own
- K182091: Osstem Abutment System (2019), 30 descendants of its own
- K211090: ZENEX Implant System (2022), 8 descendants of its own
- K203360: EK Implants and Abutments System (2022), 7 descendants of its own

## Indications for use
Intermezzo TM Plus are designed for use in dental implant surgery and are intended to be used in a manner in which the implants integrate with the bone (osseointegration). The system is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures.

Source page: https://510kreport.com/device/K053354
Methodology: https://510kreport.com/methodology