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FDA 510(k)

CERAMAX

K-Number: K062504 · 2006-09-05

ApplicantAlphadent Co., Ltd.
Decision Date2006-09-05
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERAMAX is the device name listed in this FDA 510(k) record. The listed applicant is Alphadent Co., Ltd.. It received FDA 510(k) clearance on 2006-09-05 under 510(k) number K062504. 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 CERAMAX?

CERAMAX is a medical device that received FDA 510(k) clearance on 2006-09-05. The listed applicant is Alphadent Co., Ltd.. The 510(k) number is K062504.

When did CERAMAX receive FDA 510(k) clearance?

CERAMAX received FDA 510(k) clearance on 2006-09-05, under 510(k) number K062504.

Who is the listed applicant for CERAMAX?

The FDA 510(k) record lists Alphadent Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CERAMAX?

The FDA product code for CERAMAX is EIH.

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Related Devices (Code: 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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