Cleared Traditional

Integral Dental Unit

K243130 · Guangdong Yadeng Medical Apparatus Co., Ltd., · Dental

Jun 2025

Decision

270d

Days

Class 1

Risk

About This 510(k) Submission

K243130 is an FDA 510(k) clearance for the Integral Dental Unit, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Guangdong Yadeng Medical Apparatus Co., Ltd., (Foshan, CN). The FDA issued a Cleared decision on June 27, 2025, 270 days after receiving the submission on September 30, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number	K243130 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2024
Decision Date	June 27, 2025
Days to Decision	270 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF