Obsidian® Press Over Zirconia— 510(k) K262239

Name: FDA 510(k) clearance K262239
Creator: U.S. Food and Drug Administration
Published: 2026-07-30

Substantially Equivalent

Prismatik Dentalcraft, Inc.

FDA 510(k) clearance K262239 for Obsidian® Press Over Zirconia, Substantially Equivalent on 2026-07-30. Applicant: Prismatik Dentalcraft, Inc.. Device class: 2.

Clearance details

Applicant: Prismatik Dentalcraft, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2026-07-01
Decision date: 2026-07-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.