Cleared Traditional

POINT 4 MODIFIED

K013510 · Sybron Dental Specialties, Inc. · Dental
Jan 2002
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K013510 is an FDA 510(k) clearance for the POINT 4 MODIFIED, 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 January 18, 2002, 88 days after receiving the submission on October 22, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K013510 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2001
Decision Date January 18, 2002
Days to Decision 88 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