K250473 is an FDA 510(k) clearance for the Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Dci International, LLC (Newberg, US). The FDA issued a Cleared decision on February 19, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K250473 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2025 |
| Decision Date | February 19, 2025 |
| Days to Decision | - |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EIA - Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |