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FDA 510(k)

Dental Image Plate Scanner, Model DFC-4T-SMART

K-Number: K214091 · 2022-03-02

ApplicantHefei Dentafilm Medical Equipment Co., Ltd.
Decision Date2022-03-02
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Image Plate Scanner, Model DFC-4T-SMART is the device name listed in this FDA 510(k) record. The listed applicant is Hefei Dentafilm Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K214091. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Image Plate Scanner, Model DFC-4T-SMART?

Dental Image Plate Scanner, Model DFC-4T-SMART is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Hefei Dentafilm Medical Equipment Co., Ltd.. The 510(k) number is K214091.

When did Dental Image Plate Scanner, Model DFC-4T-SMART receive FDA 510(k) clearance?

Dental Image Plate Scanner, Model DFC-4T-SMART received FDA 510(k) clearance on 2022-03-02, under 510(k) number K214091.

Who is the listed applicant for Dental Image Plate Scanner, Model DFC-4T-SMART?

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

What is the FDA product code for Dental Image Plate Scanner, Model DFC-4T-SMART?

The FDA product code for Dental Image Plate Scanner, Model DFC-4T-SMART is MUH.

Related Clinical Trials

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.

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Related Devices (Code: MUH)

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.

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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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