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Microlux/Dl Microlux/Blu Bio/Screen

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121282

by Addent, Inc.

Identifiers

510(k) Number
K121282 FDA 510(k)
FDA Product Code
NXV FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.6350 FDA 510(k)
Regulation Number
872.6350 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Microlux/Dl Microlux/Blu Bio/Screen by Addent, Inc. — 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
Addent, Inc.

Sources (1)

  • FDA 510(k) K121282 24 fields · synced Jun 18, 2026