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FDA 510(k)

CAULK OPAQUER

K-Number: K813357 · 1982-01-07

ApplicantDentsply Intl.
Decision Date1982-01-07
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CAULK OPAQUER is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1982-01-07 under 510(k) number K813357. 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 CAULK OPAQUER?

CAULK OPAQUER is a medical device that received FDA 510(k) clearance on 1982-01-07. The listed applicant is Dentsply Intl.. The 510(k) number is K813357.

When did CAULK OPAQUER receive FDA 510(k) clearance?

CAULK OPAQUER received FDA 510(k) clearance on 1982-01-07, under 510(k) number K813357.

Who is the listed applicant for CAULK OPAQUER?

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 CAULK OPAQUER?

The FDA product code for CAULK OPAQUER is 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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