BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205— 510(k) K091852

Name: FDA 510(k) clearance K091852
Creator: U.S. Food and Drug Administration
Published: 2009-09-10

Substantially Equivalent

Refractron Technologies Corp.

FDA 510(k) clearance K091852 for BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205, Substantially Equivalent on 2009-09-10. Applicant: Refractron Technologies Corp.. Device class: 2.

Clearance details

Applicant: Refractron Technologies Corp.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2009-06-23
Decision date: 2009-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maineville, OH, US

Download summary PDF View on FDA.gov ↗

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