# K191127: Advanced Intermezzo Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Oct 8, 2019 after 162 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.
No later device cites it as a predicate yet.
0 of 2 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 4.

## Indications for use
Advanced Intermezzo Implant Systems is threaded one-piece implants designed for orthodontic one-stage surgical procedures in upper and lower jaw to provide a means of prosthetic attachment to restore a patient's chewing function. Advanced Intermezzo Implant System consists of single-stage, root-form dental implants. The system is designed to provide immediate provisional implant to provide temporary support for prosthetic devices during the healing phase of permanent root form implants. Depends on a patient's quality of bone condition, Advanced Intermezzo Fixtures are to be removed within six to ten weeks after the surgery. The system is intended for immediate placement in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations.

Source page: https://510kreport.com/device/K191127
Methodology: https://510kreport.com/methodology