PRISMATIK CERAMIC— 510(k) K050144

Substantially Equivalent

Glidewell Laboratories

FDA 510(k) clearance K050144 for PRISMATIK CERAMIC, Substantially Equivalent on 2005-03-03. Applicant: Glidewell Laboratories. Device class: 2.

Clearance details

Applicant: Glidewell Laboratories
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2005-01-24
Decision date: 2005-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

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