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FDA 510(k)

Dental X-RAY Unit (AJX200)

K-Number: K252110 · 2026-03-12

Decision Date2026-03-12
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental X-RAY Unit (AJX200) is a medical device manufactured by Guangzhou Ajax Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-03-12 under approval number K252110. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental X-RAY Unit (AJX200)?

Dental X-RAY Unit (AJX200) is a medical device that received FDA 510(k) clearance on 2026-03-12. It is manufactured by Guangzhou Ajax Medical Equipment Co., Ltd.. The 510(k) number is K252110.

When was Dental X-RAY Unit (AJX200) approved by the FDA?

Dental X-RAY Unit (AJX200) received FDA 510(k) clearance on 2026-03-12, under approval number K252110.

What company makes Dental X-RAY Unit (AJX200)?

Dental X-RAY Unit (AJX200) is manufactured by Guangzhou Ajax Medical Equipment Co., Ltd..

What is the FDA product code for Dental X-RAY Unit (AJX200)?

The FDA product code for Dental X-RAY Unit (AJX200) is EHD.

Other Devices by Guangzhou Ajax Medical Equipment Co., Ltd.

Related Devices (Code: EHD)

Official Source

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