Integral Dental Unit— 510(k) K243130

Name: FDA 510(k) clearance K243130
Creator: U.S. Food and Drug Administration
Published: 2025-06-27

Substantially Equivalent

Guangdong Yadeng Medical Apparatus Co., Ltd.,

FDA 510(k) clearance K243130 for Integral Dental Unit, Substantially Equivalent on 2025-06-27. Applicant: Guangdong Yadeng Medical Apparatus Co., Ltd.,. Device class: 1.

Clearance details

Applicant: Guangdong Yadeng Medical Apparatus Co., Ltd.,
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2024-09-30
Decision date: 2025-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foshan, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIA

view all

K251544 — Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)2026-08-07
K251626 — Midmark Dental Delivery System2025-11-03
K251491 — K5 Cart, K5 Mount, K5 Swing2025-07-17
K242611 — Integral Dental Units2025-05-27
K250473 — Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus2025-02-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.