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FDA 510(k)

DUCERAGOLD PORCELAINS

K-Number: K040421 · 2004-03-18

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

Device Summary

DUCERAGOLD PORCELAINS 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 K040421. 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 DUCERAGOLD PORCELAINS?

DUCERAGOLD PORCELAINS 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 K040421.

When did DUCERAGOLD PORCELAINS receive FDA 510(k) clearance?

DUCERAGOLD PORCELAINS received FDA 510(k) clearance on 2004-03-18, under 510(k) number K040421.

Who is the listed applicant for DUCERAGOLD PORCELAINS?

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 DUCERAGOLD PORCELAINS?

The FDA product code for DUCERAGOLD PORCELAINS 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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