Cleared Traditional

PREMISE

K032921 · Sybron Dental Specialties, Inc. · Dental
Nov 2003
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K032921 is an FDA 510(k) clearance for the PREMISE, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on November 13, 2003, 52 days after receiving the submission on September 22, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K032921 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2003
Decision Date November 13, 2003
Days to Decision 52 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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