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FDA 510(k)

KDF Zirconia Disc

K-Number: K221429 · 2022-07-14

ApplicantDenken-Highdental Co., Ltd.
Decision Date2022-07-14
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KDF Zirconia Disc is a medical device manufactured by Denken-Highdental Co., Ltd.. It received FDA 510(k) clearance on 2022-07-14 under approval number K221429. 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 KDF Zirconia Disc?

KDF Zirconia Disc is a medical device that received FDA 510(k) clearance on 2022-07-14. It is manufactured by Denken-Highdental Co., Ltd.. The 510(k) number is K221429.

When was KDF Zirconia Disc approved by the FDA?

KDF Zirconia Disc received FDA 510(k) clearance on 2022-07-14, under approval number K221429.

What company makes KDF Zirconia Disc?

KDF Zirconia Disc is manufactured by Denken-Highdental Co., Ltd..

What is the FDA product code for KDF Zirconia Disc?

The FDA product code for KDF Zirconia Disc is EIH.

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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.

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