FDA Product Code
FDA Product Code QNO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.5575
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240328 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | Signifier Medical Technologies, Ltd. | 2024-05-16 | Special | PDF ↗ |
| K223446 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | Signifier Medical Technologies, Ltd. | 2023-01-18 | Special | PDF ↗ |
| DEN200018 | eXciteOSA with remote and eXciteOSA without remote | Signifier Medical Technologies | 2021-02-05 | Direct | — |
Product code QNO · Class II · Dental. Data: openFDA.