Cleared Traditional

UltraTemp Rez II

K211237 · Ultradent Products, Inc. · Dental
Jul 2021
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K211237 is an FDA 510(k) clearance for the UltraTemp Rez II, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on July 13, 2021, 78 days after receiving the submission on April 26, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K211237 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2021
Decision Date July 13, 2021
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275