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EzDent-i - E2

FDA 510(k)

Class II (US FDA 510(k))

510(k) K163533

by Ewoosoft Co., Ltd.

Identifiers

510(k) Number
K163533 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)
Models / Variants
EzDent-i FDA 510(k)
E2 FDA 510(k)
ProraView FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

EzDent-i - E2 by Ewoosoft Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 3 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ewoosoft Co., Ltd.

Sources (1)

  • FDA 510(k) K163533 24 fields · synced Jun 18, 2026