UltraTemp Rez II
FDA 510(k) K211237 · Ultradent Products, Inc.
510(k) numberK211237
Submission
- Device name
- UltraTemp Rez II
- Applicant
- Ultradent Products, Inc.
South Jordan, UT, US - Received
- April 26, 2021
- Decision date
- July 13, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was UltraTemp Rez II cleared by the FDA?
UltraTemp Rez II (K211237) received a 510(k) decision of Substantially Equivalent on July 13, 2021, 78 days after the submission was received.
What is the product code of K211237?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.