K230905 is an FDA 510(k) clearance for the OrthoPulse 2.0E (OPi2E-100). This device is classified as a Orthodontic Led Accessory (Class II - Special Controls, product code PLH).
Submitted by Biolux Technology GmbH (Absdorf, AT). The FDA issued a Cleared decision on June 9, 2023, 70 days after receiving the submission on March 31, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470. Intended For Use During Orthodontic Treatment. It Is Used In Conjunction With Brackets And Wires Or Aligners And Helps Facilitate Minor Anterior Tooth Movement..
| 510(k) Number | K230905 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2023 |
| Decision Date | June 09, 2023 |
| Days to Decision | 70 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | PLH - Orthodontic Led Accessory |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5470 |
| Definition | Intended For Use During Orthodontic Treatment. It Is Used In Conjunction With Brackets And Wires Or Aligners And Helps Facilitate Minor Anterior Tooth Movement. |