Estelite Universal Flow— 510(k) K180613

Name: FDA 510(k) clearance K180613
Creator: U.S. Food and Drug Administration
Published: 2018-07-12

Substantially Equivalent

Tokuyama Dental Corporation

FDA 510(k) clearance K180613 for Estelite Universal Flow, Substantially Equivalent on 2018-07-12. 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: 2018-03-08
Decision date: 2018-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.