Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EzDent-i / E2 / Prora View

K-Number: K190087 · 2019-02-27

ApplicantEwoosoft Co., Ltd.
Decision Date2019-02-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EzDent-i / E2 / Prora View 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 2019-02-27 under 510(k) number K190087. 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?

EzDent-i / E2 / Prora View is a medical device that received FDA 510(k) clearance on 2019-02-27. The listed applicant is Ewoosoft Co., Ltd.. The 510(k) number is K190087.

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

EzDent-i / E2 / Prora View received FDA 510(k) clearance on 2019-02-27, under 510(k) number K190087.

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

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?

The FDA product code for EzDent-i / E2 / Prora View 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

View all 27 devices →

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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.

↑