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FDA 510(k)

Dental X-ray System

K-Number: K250839 · 2026-06-11

ApplicantChangzhou Boen Zhongding Medical Technology Co., Ltd.
Decision Date2026-06-11
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: OAS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.K252353myray ProXIma X6Cefla S.C.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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