Cleared Traditional

NUCAL

K120003 · Pulpdent Corporation · Dental
Apr 2012
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K120003 is an FDA 510(k) clearance for the NUCAL, a Liner, Cavity, Calcium Hydroxide (Class II — Special Controls, product code EJK), submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on April 5, 2012, 93 days after receiving the submission on January 3, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3250.

Submission Details

510(k) Number K120003 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2012
Decision Date April 05, 2012
Days to Decision 93 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EJK — Liner, Cavity, Calcium Hydroxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3250

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