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FDA 510(k)

EzDent-i/ E2/ Prora View/ Smart M Viewer

K-Number: K211795 · 2021-10-04

ApplicantEwoosoft Co., Ltd.
Decision Date2021-10-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EzDent-i/ E2/ Prora View/ Smart M Viewer 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 2021-10-04 under 510(k) number K211795. 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-i/ E2/ Prora View/ Smart M Viewer?

EzDent-i/ E2/ Prora View/ Smart M Viewer is a medical device that received FDA 510(k) clearance on 2021-10-04. The listed applicant is Ewoosoft Co., Ltd.. The 510(k) number is K211795.

When did EzDent-i/ E2/ Prora View/ Smart M Viewer receive FDA 510(k) clearance?

EzDent-i/ E2/ Prora View/ Smart M Viewer received FDA 510(k) clearance on 2021-10-04, under 510(k) number K211795.

Who is the listed applicant for EzDent-i/ E2/ Prora View/ Smart M Viewer?

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-i/ E2/ Prora View/ Smart M Viewer?

The FDA product code for EzDent-i/ E2/ Prora View/ Smart M Viewer 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.

K250005Clever OneK241114EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)K231757Ez3D-i /E3K230468EzDent WebK223820EzDent-i / E2 / Prora View/ Smart M ViewerK222069Ez3D-i/E3

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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.

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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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