Integral Dental Unit

FDA 510(k) K243130 · Guangdong Yadeng Medical Apparatus Co., Ltd.,

Substantially Equivalent

510(k) numberK243130

Submission

Device name
Integral Dental Unit
Applicant
Guangdong Yadeng Medical Apparatus Co., Ltd.,
Foshan, CN
Received
September 30, 2024
Decision date
June 27, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EIA – Unit, Operative Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.6640
Specialty
Dental

Other 510(k)s with product code EIA

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K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)EIA · Traditional Lakong Medical Devices Co., Ltd.08/07/2026SE
K251626Midmark Dental Delivery SystemEIA · Traditional Midmark Corporation11/03/2025SE
K251491K5 Cart, K5 Mount, K5 SwingEIA · Special Osstem Implant Company., Ltd. Chair Business07/17/2025SE
K242611Integral Dental UnitsEIA · Traditional Mipont Medical Equipment Co., Ltd.05/27/2025SE
K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusEIA · Traditional Dci International, LLC02/19/2025SE
K242404BDC Dental UnitEIA · Traditional Bdc Dental Corporation , Ltd.02/07/2025SE
K231297Firstar Dental UnitEIA · Traditional Firstar Dental Company01/27/2025SE
K233805K5EIA · Traditional Osstem Implant Co., Ltd. Chair Business09/03/2024SE
K240754N2EIA · Special Megagen Implant Co., Ltd.03/21/2024SE
K231845Dental unit Model: MareEIA · Traditional Foshan Safety Medical Equipment Co., Ltd.02/28/2024SE

Questions and answers

When was Integral Dental Unit cleared by the FDA?

Integral Dental Unit (K243130) received a 510(k) decision of Substantially Equivalent on June 27, 2025, 270 days after the submission was received.

What is the product code of K243130?

The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.