FDA 510(k)

RESUBMITTED EMA DENTIN CEMENT

K-Number: K883770 · 1988-11-30

Decision Date1988-11-30

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

RESUBMITTED EMA DENTIN CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is G-C Intl. Corp.. It received FDA 510(k) clearance on 1988-11-30 under 510(k) number K883770. 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 RESUBMITTED EMA DENTIN CEMENT?

RESUBMITTED EMA DENTIN CEMENT is a medical device that received FDA 510(k) clearance on 1988-11-30. The listed applicant is G-C Intl. Corp.. The 510(k) number is K883770.

When did RESUBMITTED EMA DENTIN CEMENT receive FDA 510(k) clearance?

RESUBMITTED EMA DENTIN CEMENT received FDA 510(k) clearance on 1988-11-30, under 510(k) number K883770.

Who is the listed applicant for RESUBMITTED EMA DENTIN CEMENT?

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

What is the FDA product code for RESUBMITTED EMA DENTIN CEMENT?

The FDA product code for RESUBMITTED EMA DENTIN CEMENT is EMA.

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Related Devices (Code: EMA)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.