CAD/CAMouflage Milling Block— 510(k) K162537

Name: FDA 510(k) clearance K162537
Creator: U.S. Food and Drug Administration
Published: 2016-11-16

Substantially Equivalent

Prismatik Dentalcraft, Inc.

FDA 510(k) clearance K162537 for CAD/CAMouflage Milling Block, Substantially Equivalent on 2016-11-16. Applicant: Prismatik Dentalcraft, Inc.. Device class: 2.

Clearance details

Applicant: Prismatik Dentalcraft, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2016-09-12
Decision date: 2016-11-16
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.