FDA 510(k)

Dental X-ray System

Número K: K250839 · 2026-06-11

RequerenteChangzhou Boen Zhongding Medical Technology Co., Ltd.

Data da decisão2026-06-11

Código do produtoOAS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Boen Zhongding Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K250839. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dental X-ray System?

Dental X-ray System is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Changzhou Boen Zhongding Medical Technology Co., Ltd.. The 510(k) number is K250839.

When did Dental X-ray System receive FDA 510(k) clearance?

Dental X-ray System received FDA 510(k) clearance on 2026-06-11, under 510(k) number K250839.

Who is the listed applicant for Dental X-ray System?

The FDA 510(k) record lists Changzhou Boen Zhongding Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental X-ray System?

The FDA product code for Dental X-ray System is OAS.

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