Cleared Traditional

EMBRACE WETBOND CLEAR SEALANT

K052281 · Pulpdent Corporation · Dental
Feb 2006
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K052281 is an FDA 510(k) clearance for the EMBRACE WETBOND CLEAR SEALANT, 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 February 8, 2006, 170 days after receiving the submission on August 22, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3765.

Submission Details

510(k) Number K052281 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2005
Decision Date February 08, 2006
Days to Decision 170 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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