# K223909: R2GATE Lite TM

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Oct 20, 2023 after 295 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K954678 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190096: R2GATE, Megagen Implant Co., Ltd. (2019) Summary page 4.

## Indications for use
R2GATE Lite TM is intended for use as a pre-planning software for dental implant placement and surgical treatment for adult only. R2GATE Lite TM allows for surgical guides to be export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires FDA cleared or legally marketed 3D printing fabrication method and compatible material (biocompatible and sterilizable ).

Source page: https://510kreport.com/device/K223909
Methodology: https://510kreport.com/methodology