KDF Zirconia Disc— 510(k) K221429

Substantially Equivalent

Denken-Highdental Co., Ltd.

FDA 510(k) clearance K221429 for KDF Zirconia Disc, Substantially Equivalent on 2022-07-14. Applicant: Denken-Highdental Co., Ltd.. Device class: 2.

Clearance details

Applicant: Denken-Highdental Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2022-05-16
Decision date: 2022-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kisshoin Ishiharakyomichi-Cho, Minami-Ku, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.