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FDA 510(k)

Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )

K-Number: K251438 · 2025-09-04

ApplicantGuilin Woodpecker Medical Instrument Co., Ltd.
Decision Date2025-09-04
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K251438. 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 Device (Ai Ray Lite, Ai Ray Pro, Master Ray )?

Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K251438.

When did Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) receive FDA 510(k) clearance?

Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) received FDA 510(k) clearance on 2025-09-04, under 510(k) number K251438.

Who is the listed applicant for Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )?

The FDA 510(k) record lists Guilin Woodpecker Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )?

The FDA product code for Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) is EHD.

Other records listing Guilin Woodpecker Medical Instrument Co., Ltd. as applicant

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.

K222569Ai Ray Dental X-Ray DeviceK211358Implanter incl. AccessoriesK221548Dental Air Polishing HandpieceK210367D-Laser Blue, D-Laser 16K203706Dental Electric MotorK211531Cordless Prophy System, Model: i-Polish

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Related Devices (Code: EHD)

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.

K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies CorporationK252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument Co., Ltd.K242185Rextar ProRaypia Co., Ltd.

Official Source

View on FDA Database →

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

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