Cleared Traditional

OPAL BAND CEMENT

K111696 · Ultradent Products, Inc. · Dental
Sep 2011
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K111696 is an FDA 510(k) clearance for the OPAL BAND CEMENT, a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH), submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 7, 2011, 82 days after receiving the submission on June 17, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K111696 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2011
Decision Date September 07, 2011
Days to Decision 82 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DYH — Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3750

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