FDA 510(k)

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

K-Number: K202116 · 2020-08-21

Decision Date2020-08-21

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EzDent-i/ E2/ Prora View/ Smart M Viewer is a medical device manufactured by Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2020-08-21 under approval number K202116. 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 2020-08-21. It is manufactured by Ewoosoft Co., Ltd.. The 510(k) number is K202116.

When was EzDent-i/ E2/ Prora View/ Smart M Viewer approved by the FDA?

EzDent-i/ E2/ Prora View/ Smart M Viewer received FDA 510(k) clearance on 2020-08-21, under approval number K202116.

What company makes EzDent-i/ E2/ Prora View/ Smart M Viewer?

EzDent-i/ E2/ Prora View/ Smart M Viewer is manufactured by Ewoosoft Co., Ltd..

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 Devices by Ewoosoft Co., Ltd.

K163539Ez3D-i / E3 K161246Ez3D-i / E3 K161117EzDent-i / E2 / Prora View K152746Ez3D Plus K173094OrthoVision K172364EzDent-i / E2 / Prora View

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Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.