ESTECEM— 510(k) K150727

Substantially Equivalent

Tokuyama Dental Corporation

FDA 510(k) clearance K150727 for ESTECEM, Substantially Equivalent on 2015-06-17. Applicant: Tokuyama Dental Corporation. Device class: 2.

Clearance details

Applicant: Tokuyama Dental Corporation
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2015-03-20
Decision date: 2015-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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More clearances from Tokuyama Dental Corporation

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