Cleared Traditional

BDC Dental Unit

K242404 · Bdc Dental Corporation , Ltd. · Dental

Feb 2025

Decision

178d

Days

Class 1

Risk

About This 510(k) Submission

K242404 is an FDA 510(k) clearance for the BDC Dental Unit, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Bdc Dental Corporation , Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 7, 2025, 178 days after receiving the submission on August 13, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number	K242404 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 13, 2024
Decision Date	February 07, 2025
Days to Decision	178 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF