K232222 is an FDA 510(k) clearance for the Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo). This device is classified as a Laser, Dental, Soft Tissue (Class II - Special Controls, product code NVK).
Submitted by Medency S.R.L. (Vicenza, IT). The FDA issued a Cleared decision on November 27, 2023, 124 days after receiving the submission on July 26, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 878.4810. Intended For The Incision, Excision, Cutting, Ablation, And Vaporization Of Soft Tissue In Oral And Maxillofacial Surgery And Dentistry..
| 510(k) Number | K232222 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2023 |
| Decision Date | November 27, 2023 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NVK - Laser, Dental, Soft Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | Intended For The Incision, Excision, Cutting, Ablation, And Vaporization Of Soft Tissue In Oral And Maxillofacial Surgery And Dentistry. |