ZIRCONIA BLANKS (ZIRCOSTAR)— 510(k) K120852

Substantially Equivalent

Kerox, Ltd.

FDA 510(k) clearance K120852 for ZIRCONIA BLANKS (ZIRCOSTAR), Substantially Equivalent on 2012-06-06. Applicant: Kerox, Ltd.. Device class: 2.

Clearance details

Applicant: Kerox, Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2012-03-21
Decision date: 2012-06-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Great Neck, NY, 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.