Cleared Traditional

K112574 - PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT
(FDA 510(k) Clearance)

K112574 · Prime Dental Manufacturing, Inc. · Dental
Jan 2012
Decision
139d
Days
Class 2
Risk

K112574 is an FDA 510(k) clearance for the PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Prime Dental Manufacturing, Inc. (Chicago, US). The FDA issued a Cleared decision on January 23, 2012, 139 days after receiving the submission on September 6, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K112574 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2011
Decision Date January 23, 2012
Days to Decision 139 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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