Cleared Traditional

Integral Dental Units

K242611 · Mipont Medical Equipment Co., Ltd. · Dental

May 2025

Decision

266d

Days

Class 1

Risk

About This 510(k) Submission

K242611 is an FDA 510(k) clearance for the Integral Dental Units, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Mipont Medical Equipment Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on May 27, 2025, 266 days after receiving the submission on September 3, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number	K242611 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 03, 2024
Decision Date	May 27, 2025
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF