K203396 is an FDA 510(k) clearance for the DEKA SMARTPERIO. This device is classified as a Laser, Dental, Soft Tissue (Class II - Special Controls, product code NVK).
Submitted by El.En Electronic Engineering Spa (Calenzano, IT). The FDA issued a Cleared decision on August 23, 2021, 278 days after receiving the submission on November 18, 2020.
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 | K203396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2020 |
| Decision Date | August 23, 2021 |
| Days to Decision | 278 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. |