Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ADAMANT ZIRCONIA DISC

K-Number: K160203 · 2016-10-19

ApplicantAdamant Co., Ltd.
Decision Date2016-10-19
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADAMANT ZIRCONIA DISC is a medical device manufactured by Adamant Co., Ltd.. It received FDA 510(k) clearance on 2016-10-19 under approval 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. It is manufactured by Adamant Co., Ltd.. The 510(k) number is K160203.

When was ADAMANT ZIRCONIA DISC approved by the FDA?

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

What company makes ADAMANT ZIRCONIA DISC?

ADAMANT ZIRCONIA DISC is manufactured by Adamant Co., Ltd..

What is the FDA product code for ADAMANT ZIRCONIA DISC?

The FDA product code for ADAMANT ZIRCONIA DISC is EIH.

Related Devices (Code: EIH)

K162677L- OVCRhondium, Ltd. K160079rainbow ShineGenoss Co., Ltd. K160262n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,Institut Straumann AG K152023Luminesse Shaded Zirconia SZTalladium, Inc. K153130Initial LiSi BlockGC America, Inc. K160867Pavati Z40.2 ZirconiaCcri, Inc.

Official Source

View on FDA Database →

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

↑