Cleared Special

ULTRASEAL ID

K101245 · Ultradent Products, Inc. · Dental
Sep 2010
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K101245 is an FDA 510(k) clearance for the ULTRASEAL ID, 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 17, 2010, 136 days after receiving the submission on May 4, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3765.

Submission Details

510(k) Number K101245 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2010
Decision Date September 17, 2010
Days to Decision 136 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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