KDF Zirconia Disc

Powder, Porcelain

DENKEN-HIGHDENTAL Co., Ltd.

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

Pre-market Notification Details

Device IDK221429
510k NumberK221429
Device Name:KDF Zirconia Disc
ClassificationPowder, Porcelain
Applicant DENKEN-HIGHDENTAL Co., Ltd. 24-3 Kisshoin Ishiharakyomichi-cho, Minami-ku,  JP 601-8356
ContactDaijiro Goto
CorrespondentNoriko Tanji
DENKEN-HIGHDENTAL Co., Ltd. 24-3 Kisshoin Ishiharakyomichi-cho Minami-ku,  JP 601-8356
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-16
Decision Date2022-07-14

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