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FDA 510(k)

DYRACT EXTRA RESTORATIVE

K-Number: K050880 · 2005-04-22

ApplicantDentsply Intl.
Decision Date2005-04-22
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DYRACT EXTRA RESTORATIVE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2005-04-22 under 510(k) number K050880. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYRACT EXTRA RESTORATIVE?

DYRACT EXTRA RESTORATIVE is a medical device that received FDA 510(k) clearance on 2005-04-22. The listed applicant is Dentsply Intl.. The 510(k) number is K050880.

When did DYRACT EXTRA RESTORATIVE receive FDA 510(k) clearance?

DYRACT EXTRA RESTORATIVE received FDA 510(k) clearance on 2005-04-22, under 510(k) number K050880.

Who is the listed applicant for DYRACT EXTRA RESTORATIVE?

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 DYRACT EXTRA RESTORATIVE?

The FDA product code for DYRACT EXTRA RESTORATIVE is EBF.

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Related Devices (Code: EBF)

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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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