Cleared Traditional

J-Temp

K221909 · Ultradent Products, Inc. · Dental
Jul 2022
Decision
1d
Days
Class 2
Risk

About This 510(k) Submission

K221909 is an FDA 510(k) clearance for the J-Temp, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on July 1, 2022, 1 days after receiving the submission on June 30, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K221909 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2022
Decision Date July 01, 2022
Days to Decision 1 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690