Cleared Traditional

OPAL BOND MV

K094006 · Ultradent Products, Inc. · Dental
Mar 2010
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K094006 is an FDA 510(k) clearance for the OPAL BOND MV, 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 March 23, 2010, 85 days after receiving the submission on December 28, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K094006 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2009
Decision Date March 23, 2010
Days to Decision 85 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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