FDA 510(k)

DUO TEMP

K-Number: K072604 · 2007-11-16

Decision Date2007-11-16

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DUO TEMP is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent AG. It received FDA 510(k) clearance on 2007-11-16 under 510(k) number K072604. 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 DUO TEMP?

DUO TEMP is a medical device that received FDA 510(k) clearance on 2007-11-16. The listed applicant is Coltene/Whaledent AG. The 510(k) number is K072604.

When did DUO TEMP receive FDA 510(k) clearance?

DUO TEMP received FDA 510(k) clearance on 2007-11-16, under 510(k) number K072604.

Who is the listed applicant for DUO TEMP?

The FDA 510(k) record lists Coltene/Whaledent AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUO TEMP?

The FDA product code for DUO TEMP is EMA.

Other records listing Coltene/Whaledent AG as applicant

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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.