Cleared Traditional

Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus

K250473 · Dci International, LLC · Dental

Feb 2025

Decision

—

Days

Class 1

Risk

About This 510(k) Submission

K250473 is an FDA 510(k) clearance for the Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus, 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 review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number	K250473 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2025
Decision Date	February 19, 2025
Days to Decision	—
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement