K232076 is an FDA 510(k) clearance for the Fibercure. This device is classified as a Laser Activator For Polymerization (Class II - Special Controls, product code QNF).
Submitted by Lumendo AG (Renens, CH). The FDA issued a Cleared decision on November 2, 2023, 112 days after receiving the submission on July 13, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070. Intended To Polymerize Dental Restorative Resins.
| 510(k) Number | K232076 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2023 |
| Decision Date | November 02, 2023 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | QNF - Laser Activator For Polymerization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6070 |
| Definition | Intended To Polymerize Dental Restorative Resins |