Cleared Traditional

3M RelyX Pediatric Resin Modified Glass Ionomer Cement

K191122 · 3M Espe Dental Products · Dental
May 2019
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K191122 is an FDA 510(k) clearance for the 3M RelyX Pediatric Resin Modified Glass Ionomer Cement, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by 3M Espe Dental Products (Saint Paul, US). The FDA issued a Cleared decision on May 29, 2019, 30 days after receiving the submission on April 29, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K191122 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2019
Decision Date May 29, 2019
Days to Decision 30 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