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Flexible Partial Resin

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250302

by Prismatik Dentalcraft, Inc.

Identifiers

510(k) Number
K250302 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)

Flexible Partial Resin by Prismatik Dentalcraft, 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

Sources (1)

  • FDA 510(k) K250302 24 fields · synced Jun 18, 2026