ADAMANT ZIRCONIA DISC— 510(k) K160203

Substantially Equivalent

Adamant Co., Ltd.

FDA 510(k) clearance K160203 for ADAMANT ZIRCONIA DISC, Substantially Equivalent on 2016-10-19. Applicant: Adamant Co., Ltd.. Device class: 2.

Clearance details

Applicant: Adamant Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2016-01-28
Decision date: 2016-10-19
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.