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FDA 510(k)

EzDent Web

K-Number: K211700 · 2021-09-28

Decision Date2021-09-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EzDent Web is the device name listed in this FDA 510(k) record. The listed applicant is Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2021-09-28 under 510(k) number K211700. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EzDent Web?

EzDent Web is a medical device that received FDA 510(k) clearance on 2021-09-28. The listed applicant is Ewoosoft Co., Ltd.. The 510(k) number is K211700.

When did EzDent Web receive FDA 510(k) clearance?

EzDent Web received FDA 510(k) clearance on 2021-09-28, under 510(k) number K211700.

Who is the listed applicant for EzDent Web?

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

What is the FDA product code for EzDent Web?

The FDA product code for EzDent Web is LLZ.

Other records listing Ewoosoft 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.

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Related Devices (Code: LLZ)

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.

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.