Cleared Traditional

UltraCal XS

K211905 · Ultradent Products, Inc. · Dental
Oct 2021
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K211905 is an FDA 510(k) clearance for the UltraCal XS, a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on October 13, 2021, 114 days after receiving the submission on June 21, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K211905 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2021
Decision Date October 13, 2021
Days to Decision 114 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KIF — Resin, Root Canal Filling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3820