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LuxCreo Flexible Partial Denture Resin

FDA 510(k)

Class II (US FDA 510(k))

510(k) K253365

by LuxCreo, Inc.

Identifiers

510(k) Number
K253365 FDA 510(k)
FDA Product Code
EBI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3760 FDA 510(k)
Regulation Number
872.3760 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

LuxCreo Flexible Partial Denture Resin by LuxCreo, 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
LuxCreo, Inc.

Sources (1)

  • FDA 510(k) K253365 24 fields · synced Jun 18, 2026