# K241972: Bluediamond Implant

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Dec 27, 2024 after 175 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: 15 generations back to K925765 (1993). 218 ancestors in all.
No later device cites it as a predicate yet.
0 of 219 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231967: ARi ExCon Implant System, Megagen Implant Co., Ltd. (2023) Summary page 5.

## Indications for use
The BLUEDIAMOND IMPLANT is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: - Delayed loading - Immediate loading when good primary stability is achieved and with appropriate occlusal loading. For the BLUEDIAMOND IMPLANTS with a Thread Length of 5mm, It is indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks. It is specifically recommended for: - Fixed partial dentures/splinted units (one implant per unit) - Pontic cases in combination with at least one longer implant - Fully edentulous cases with at least one 5 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants

Source page: https://510kreport.com/device/K241972
Methodology: https://510kreport.com/methodology