Cleared Traditional

K040236 - PULPDENT VLC RESIN CEMENT
(FDA 510(k) Clearance)

K040236 · Pulpdent Corporation · Dental
Apr 2004
Decision
78d
Days
Class 2
Risk

K040236 is an FDA 510(k) clearance for the PULPDENT VLC RESIN CEMENT, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on April 20, 2004, 78 days after receiving the submission on February 2, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K040236 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2004
Decision Date April 20, 2004
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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