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FDA 510(k)

CALIBRA CEMENT

K-Number: K040906 · 2004-06-16

ApplicantDentsply Intl.
Decision Date2004-06-16
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CALIBRA CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2004-06-16 under 510(k) number K040906. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALIBRA CEMENT?

CALIBRA CEMENT is a medical device that received FDA 510(k) clearance on 2004-06-16. The listed applicant is Dentsply Intl.. The 510(k) number is K040906.

When did CALIBRA CEMENT receive FDA 510(k) clearance?

CALIBRA CEMENT received FDA 510(k) clearance on 2004-06-16, under 510(k) number K040906.

Who is the listed applicant for CALIBRA CEMENT?

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 CALIBRA CEMENT?

The FDA product code for CALIBRA CEMENT is EMA.

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Related Devices (Code: EMA)

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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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