OBSIDIAN CERAMIC BLOCKS— 510(k) K100781

Name: FDA 510(k) clearance K100781
Creator: U.S. Food and Drug Administration
Published: 2010-06-21

Substantially Equivalent

Prismatik Dentalcraft, Inc.

FDA 510(k) clearance K100781 for OBSIDIAN CERAMIC BLOCKS, Substantially Equivalent on 2010-06-21. 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: 2010-03-19
Decision date: 2010-06-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Newport Beach, 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.