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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04560230233808 K221429 000
04560230233921 K221429 000
04560230233914 K221429 000
04560230233907 K221429 000
04560230234072 K221429 000
04560230234065 K221429 000
04560230234058 K221429 000
04560230234041 K221429 000
04560230234034 K221429 000
04560230234027 K221429 000
04560230234010 K221429 000
04560230234003 K221429 000
04560230233938 K221429 000
04560230233945 K221429 000
04560230233952 K221429 000
04560230233792 K221429 000
04560230233785 K221429 000
04560230233778 K221429 000
04560230233761 K221429 000
04560230233754 K221429 000
04560230233747 K221429 000
04560230233730 K221429 000
04560230233723 K221429 000
04560230233983 K221429 000
04560230233976 K221429 000
04560230233969 K221429 000
04560230233990 K221429 000

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