FDA Product Code
FDA Product Code PLH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.5470
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230905 | OrthoPulse 2.0E (OPi2E-100) | Biolux Technology GmbH | 2023-06-09 | Special | PDF ↗ |
| K143120 | OrthoPulse | Biolux Research , Ltd. | 2015-07-24 | Traditional | PDF ↗ |
Product code PLH · Class II · Dental. Data: openFDA.