Cleared Traditional

PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT

K012794 · Prime Dental Manufacturing, Inc. · Dental
Nov 2001
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K012794 is an FDA 510(k) clearance for the PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT, 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 5, 2001, 76 days after receiving the submission on August 21, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K012794 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2001
Decision Date November 05, 2001
Days to Decision 76 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