ADAMANT ZIRCONIA DISC

Powder, Porcelain

Adamant Co., Ltd.

The following data is part of a premarket notification filed by Adamant Co., Ltd. with the FDA for Adamant Zirconia Disc.

Pre-market Notification Details

Device IDK160203
510k NumberK160203
Device Name:ADAMANT ZIRCONIA DISC
ClassificationPowder, Porcelain
Applicant Adamant Co., Ltd. 1-16-7 Shinden, Adachi Ku Tokyo,  JP 123-8595
ContactDeborah Lavoie Grayeski
CorrespondentDeborah Lavoie Grayeski
M Squared Associates 575 Eighth Ave, Suite 1212 New York,  NY  10018
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-28
Decision Date2016-10-19
Summary:summary

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