FDA 510(k)

E.Z. TEMEP, TEMPORARY FILLING MATERIAL

K-Number: K924132 · 1993-07-08

Decision Date1993-07-08

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

E.Z. TEMEP, TEMPORARY FILLING MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 1993-07-08 under 510(k) number K924132. 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 E.Z. TEMEP, TEMPORARY FILLING MATERIAL?

E.Z. TEMEP, TEMPORARY FILLING MATERIAL is a medical device that received FDA 510(k) clearance on 1993-07-08. The listed applicant is Cosmedent, Inc.. The 510(k) number is K924132.

When did E.Z. TEMEP, TEMPORARY FILLING MATERIAL receive FDA 510(k) clearance?

E.Z. TEMEP, TEMPORARY FILLING MATERIAL received FDA 510(k) clearance on 1993-07-08, under 510(k) number K924132.

Who is the listed applicant for E.Z. TEMEP, TEMPORARY FILLING MATERIAL?

The FDA 510(k) record lists Cosmedent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E.Z. TEMEP, TEMPORARY FILLING MATERIAL?

The FDA product code for E.Z. TEMEP, TEMPORARY FILLING MATERIAL is 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.