Cleared Traditional

Pulpdent Solo Flowable Composite with MCP

K153249 · Pulpdent Corporation · Dental
Apr 2016
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K153249 is an FDA 510(k) clearance for the Pulpdent Solo Flowable Composite with MCP, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on April 1, 2016, 144 days after receiving the submission on November 9, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K153249 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2015
Decision Date April 01, 2016
Days to Decision 144 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