FDA 510(k)

UltraTemp Rez II

K-Number: K211237 · 2021-07-13

Decision Date2021-07-13

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

UltraTemp Rez II is a medical device manufactured by Ultradent Products, Inc.. It received FDA 510(k) clearance on 2021-07-13 under approval number K211237. 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 UltraTemp Rez II?

UltraTemp Rez II is a medical device that received FDA 510(k) clearance on 2021-07-13. It is manufactured by Ultradent Products, Inc.. The 510(k) number is K211237.

When was UltraTemp Rez II approved by the FDA?

UltraTemp Rez II received FDA 510(k) clearance on 2021-07-13, under approval number K211237.

What company makes UltraTemp Rez II?

UltraTemp Rez II is manufactured by Ultradent Products, Inc..

What is the FDA product code for UltraTemp Rez II?

The FDA product code for UltraTemp Rez II 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.