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Endo-Ice

FDA 510(k)

Class II (US FDA 510(k))

510(k) K881826

by The Hygenic Corp.

Identifiers

510(k) Number
K881826 FDA 510(k)
FDA Product Code
EAT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.1720 FDA 510(k)
Regulation Number
872.1720 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SN FDA 510(k)

Endo-Ice by The Hygenic Corp. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
The Hygenic Corp.

Sources (1)

  • FDA 510(k) K881826 24 fields · synced Jun 18, 2026