K183121 is an FDA 510(k) clearance for the Qraypen. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by AIOBIO Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on July 18, 2019, 251 days after receiving the submission on November 9, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K183121 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2018 |
| Decision Date | July 18, 2019 |
| Days to Decision | 251 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIA — Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |