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FDA 510(k)

DUCERAM PLUS CERAMIC SYSTEM

K-Number: K040420 · 2004-03-18

ApplicantDentsply Intl.
Decision Date2004-03-18
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DUCERAM PLUS CERAMIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2004-03-18 under 510(k) number K040420. 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 DUCERAM PLUS CERAMIC SYSTEM?

DUCERAM PLUS CERAMIC SYSTEM is a medical device that received FDA 510(k) clearance on 2004-03-18. The listed applicant is Dentsply Intl.. The 510(k) number is K040420.

When did DUCERAM PLUS CERAMIC SYSTEM receive FDA 510(k) clearance?

DUCERAM PLUS CERAMIC SYSTEM received FDA 510(k) clearance on 2004-03-18, under 510(k) number K040420.

Who is the listed applicant for DUCERAM PLUS CERAMIC SYSTEM?

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

What is the FDA product code for DUCERAM PLUS CERAMIC SYSTEM?

The FDA product code for DUCERAM PLUS CERAMIC SYSTEM 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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