ESTELITE SIGMA QUICK— 510(k) K080940

Name: FDA 510(k) clearance K080940
Creator: U.S. Food and Drug Administration
Published: 2008-06-19

Substantially Equivalent

Tokuyama Dental Corporation

FDA 510(k) clearance K080940 for ESTELITE SIGMA QUICK, Substantially Equivalent on 2008-06-19. Applicant: Tokuyama Dental Corporation. Device class: 2.

Clearance details

Applicant: Tokuyama Dental Corporation
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2008-04-03
Decision date: 2008-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.