# K051018: Intermezzo Implant Systems

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Co., Ltd.
- Decided: Sep 2, 2005 after 134 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
No predicates in its family tree.
52 later devices descend from it; 6 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) IMTEC Sendax / MIDI (Mini Dental Implant System): named in the summary without a submission number
- (no number) Nobel Biocare / IPI (Immediate Provisional Implant System): named in the summary without a submission number

## Most influential descendants
- K053354: Intermezzo Plus Fixture (2006), 45 descendants of its own
- 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

## Indications for use
The Intermezzo TM Implant Systems are intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

Source page: https://510kreport.com/device/K051018
Methodology: https://510kreport.com/methodology