Cleared Traditional

RMGI FILL

K130223 · Pulpdent Corporation · Dental
Mar 2013
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K130223 is an FDA 510(k) clearance for the RMGI FILL, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on March 29, 2013, 59 days after receiving the submission on January 29, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K130223 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 2013
Decision Date March 29, 2013
Days to Decision 59 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