Integral Dental Units— 510(k) K242611

Name: FDA 510(k) clearance K242611
Creator: U.S. Food and Drug Administration
Published: 2025-05-27

Substantially Equivalent

Mipont Medical Equipment Co., Ltd.

FDA 510(k) clearance K242611 for Integral Dental Units, Substantially Equivalent on 2025-05-27. Applicant: Mipont Medical Equipment Co., Ltd.. Device class: 1.

Clearance details

Applicant: Mipont Medical Equipment Co., Ltd.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2024-09-03
Decision date: 2025-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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