# K211812: BLUEDIAMOND IMPLANT, Abutment Screw

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Jan 6, 2023 after 574 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: 3 generations back to K010185 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063216: Rescue Internal Implant System, Megagen Co., Ltd. (2007) Summary page 4.

## Indications for use
The BLUEDIAMOND IMPLANT System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed.

Source page: https://510kreport.com/device/K211812
Methodology: https://510kreport.com/methodology