# Ray Co., Ltd.

- Location (FDA's records): Hwaseong-Si, KR
- FDA decisions: 24 (2013–2026): 24 510(k) clearances
- Product codes: OAS (15), MUH (5), LLZ (1), FXX (1), PNN (1), MQB (1)
- 510(k) review time since 2016: median 56 days, against 77 for FDA's reviews in the same codes and years (13 of 17 faster)
- Predicates its devices cite: 33 (22 its own); citations of its devices by later devices: 32 (22 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Trophy: 1 (https://510kreport.com/company/trophy)
- Mexpo International, Inc.: 1 (https://510kreport.com/company/mexpo-international)
- 3Shape A/S: 1 (https://510kreport.com/company/3shape-a-s)
- Dentsply Sirona: 1 (https://510kreport.com/company/dentsply-sirona)
- Sirona Dental Systems GmbH: 1 (https://510kreport.com/company/sirona-dental-systems)
- Instrumentarium Dental, Palodex Group OY: 1 (https://510kreport.com/company/instrumentarium-dental-palodex-group)
- 3Disc Americas: 1 (https://510kreport.com/company/3disc-americas)
- Humanray Co,Ltd: 1 (https://510kreport.com/company/humanray)

## Firms that cite its devices most
- Hdx Will Corp.: 2 (https://510kreport.com/company/hdx-will)
- Hubei Kimsoul Industrial Co., Ltd.: 1 (https://510kreport.com/company/hubei-kimsoul-industrial)
- Celebrace: 1 (https://510kreport.com/company/celebrace)
- Changzhou Finno Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/changzhou-finno-medical-technology)
- Dentium Co., Ltd (Ict Branch): 1 (https://510kreport.com/company/dentium-co-ict-branch)
- Led Dental, Inc.: 1 (https://510kreport.com/company/led-dental)
- Duerr Dental AG: 1 (https://510kreport.com/company/duerr-dental)
- Megagen Implant Co., Ltd.: 1 (https://510kreport.com/company/megagen-implant)

## Its most-cited devices
- K213226: RCT700 (2021), cited by 4
- K122981: Rayscan a-Expert 3D (2013), cited by 3
- K192737: RCT800 (2019), cited by 3
- K160525: RCT700 (2016), cited by 2
- K142058: Rayscan a-Expert (2015), cited by 2
- K233625: Raydent SW (2024), cited by 2

## Recent decisions
- K260462: RCT800 (Apr 9, 2026)
- K251798: RCT700 (Nov 25, 2025)
- K251109: SMARTDent (May 21, 2025)
- K243903: RCT600 (Mar 12, 2025)
- K233625: Raydent SW (May 16, 2024)
- K232325: RAYSCAN a-Expert (Apr 18, 2024)
- K232287: RAYSCAN a-Expert3D (Aug 31, 2023)
- K230753: RCT800 (Apr 11, 2023)

Source page: https://510kreport.com/company/ray