Cleared Traditional

Nexus Universal Self-Cure

K191548 · Kerr Corporation · Dental
Oct 2019
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K191548 is an FDA 510(k) clearance for the Nexus Universal Self-Cure, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on October 11, 2019, 121 days after receiving the submission on June 12, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K191548 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2019
Decision Date October 11, 2019
Days to Decision 121 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