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FDA 510(k)

BIOCERAM AZUL® HEAD

K-Number: K243444 · 2024-12-05

ApplicantKyocera Corporation
Decision Date2024-12-05
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOCERAM AZUL® HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Corporation. It received FDA 510(k) clearance on 2024-12-05 under 510(k) number K243444. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCERAM AZUL® HEAD?

BIOCERAM AZUL® HEAD is a medical device that received FDA 510(k) clearance on 2024-12-05. The listed applicant is Kyocera Corporation. The 510(k) number is K243444.

When did BIOCERAM AZUL® HEAD receive FDA 510(k) clearance?

BIOCERAM AZUL® HEAD received FDA 510(k) clearance on 2024-12-05, under 510(k) number K243444.

Who is the listed applicant for BIOCERAM AZUL® HEAD?

The FDA 510(k) record lists Kyocera Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOCERAM AZUL® HEAD?

The FDA product code for BIOCERAM AZUL® HEAD is LZO.

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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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