# K240383: Highness Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Highness Co., Ltd.
- Decided: Oct 31, 2024 after 266 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: 13 generations back to K960026 (1996). 106 ancestors in all.
No later device cites it as a predicate yet.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182448: AnyRidge Octa 1 Implant System, Megagen Implant Co., Ltd. (2019) Summary page 5.

## Indications for use
The Highness Implant System is designed to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (crowns, bridges, and overdentures) in partially or fully edentulous individuals. It is used to the restore the patient's chewing function. Implants with diameter less than ø5.5mm are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated to the molar region and are indicated for delayed loading. The Multi-Unit Abutments are intended for multi-unit restorations only and can be used up to 25 degrees when connecting cylinder.

Source page: https://510kreport.com/device/K240383
Methodology: https://510kreport.com/methodology