Cleared Traditional

RMGI LOW VISCOSITY

K123265 · Pulpdent Corporation · Dental
Dec 2012
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K123265 is an FDA 510(k) clearance for the RMGI LOW VISCOSITY, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on December 7, 2012, 49 days after receiving the submission on October 19, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K123265 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 2012
Decision Date December 07, 2012
Days to Decision 49 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