Cleared Special

ULTRASEAL XT HYDRO

K112517 · Ultradent Products, Inc. · Dental
Sep 2011
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K112517 is an FDA 510(k) clearance for the ULTRASEAL XT HYDRO, a Sealant, Pit And Fissure, And Conditioner (Class II — Special Controls, product code EBC), submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 23, 2011, 23 days after receiving the submission on August 31, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3765.

Submission Details

510(k) Number K112517 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 2011
Decision Date September 23, 2011
Days to Decision 23 days
Submission Type Special
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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