The following data is part of a premarket notification filed by Aiobio Co., Ltd. with the FDA for Qraypen.
| Device ID | K183121 |
| 510k Number | K183121 |
| Device Name: | Qraypen |
| Classification | Unit, Operative Dental |
| Applicant | AIOBIO Co., Ltd. #306. Sunil Technopia 555, Dunchon-dacro, Jungwon-gu Seongnam-si, KR 13215 |
| Contact | Jongcheol Yoon |
| Correspondent | Kyoungju Kim MDLab Room 804, Botanic Park Tower Bldg., 161-17, Magokjungang-ro, Gangseo-gu Seoul, KR 07788 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-09 |
| Decision Date | 2019-07-18 |