Cleared Traditional

PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL

K022675 · Prime Dental Manufacturing, Inc. · Dental
Nov 2002
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K022675 is an FDA 510(k) clearance for the PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Prime Dental Manufacturing, Inc. (Chicago, US). The FDA issued a Cleared decision on November 7, 2002, 87 days after receiving the submission on August 12, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K022675 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 2002
Decision Date November 07, 2002
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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