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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 a medical device manufactured by Hefei Dentafilm Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-03-02 under approval 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. It is manufactured by Hefei Dentafilm Medical Equipment Co., Ltd.. The 510(k) number is K214091.

When was Dental Image Plate Scanner, Model DFC-4T-SMART approved by the FDA?

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

What company makes Dental Image Plate Scanner, Model DFC-4T-SMART?

Dental Image Plate Scanner, Model DFC-4T-SMART is manufactured by Hefei Dentafilm Medical Equipment Co., Ltd..

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.

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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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