FDA 510(k)

ADAMANT ZIRCONIA DISC

K-Number: K160203 · 2016-10-19

Decision Date2016-10-19

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ADAMANT ZIRCONIA DISC is the device name listed in this FDA 510(k) record. The listed applicant is Adamant Co., Ltd.. It received FDA 510(k) clearance on 2016-10-19 under 510(k) number K160203. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADAMANT ZIRCONIA DISC?

ADAMANT ZIRCONIA DISC is a medical device that received FDA 510(k) clearance on 2016-10-19. The listed applicant is Adamant Co., Ltd.. The 510(k) number is K160203.

When did ADAMANT ZIRCONIA DISC receive FDA 510(k) clearance?

ADAMANT ZIRCONIA DISC received FDA 510(k) clearance on 2016-10-19, under 510(k) number K160203.

Who is the listed applicant for ADAMANT ZIRCONIA DISC?

The FDA 510(k) record lists Adamant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADAMANT ZIRCONIA DISC?

The FDA product code for ADAMANT ZIRCONIA DISC is EIH.

Related Devices (Code: EIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba Dandy K260918Zolid LunarisAmann Girrbach AG K260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.