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DENTRIa series (DENTRIa +2 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K212254

by Hdx Will Corp.

Identifiers

510(k) Number
K212254 FDA 510(k)
FDA Product Code
OAS FDA 510(k)
Models / Variants
DENTRIa FDA 510(k)
DENTRI-Ca FDA 510(k)
DENTRI-Sa FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1750 FDA 510(k)
Regulation Number
892.1750 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

DENTRIa series (DENTRIa +2 more) by Hdx Will Corp. — 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
Hdx Will Corp.

Sources (1)

  • FDA 510(k) K212254 24 fields · synced Jun 18, 2026