K233625 is an FDA 510(k) clearance for the RAYDENT SW. This device is classified as a Orthodontic Software (Class II - Special Controls, product code PNN).
Submitted by Ray Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on May 16, 2024, 185 days after receiving the submission on November 13, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470. The Device Is Software That Is To Be Used For The Diagnosis And Treatment Planning Of Orthodontic Patients And Conditions. It May Include Orthodontic Output Devices Used For The Treatment Of Orthodontics. The Device Is Intended For Prescription Use Only..
| 510(k) Number | K233625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2023 |
| Decision Date | May 16, 2024 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | PNN — Orthodontic Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5470 |
| Definition | The Device Is Software That Is To Be Used For The Diagnosis And Treatment Planning Of Orthodontic Patients And Conditions. It May Include Orthodontic Output Devices Used For The Treatment Of Orthodontics. The Device Is Intended For Prescription Use Only. |