Cleared Traditional

EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL

K113818 · Pulpdent Corporation · Dental
Mar 2012
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K113818 is an FDA 510(k) clearance for the EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL, a Sealant, Pit And Fissure, And Conditioner (Class II — Special Controls, product code EBC), submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on March 21, 2012, 85 days after receiving the submission on December 27, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3765.

Submission Details

510(k) Number K113818 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2011
Decision Date March 21, 2012
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBC — Sealant, Pit And Fissure, And Conditioner
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3765

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