Cleared Traditional

OPAL BOND FLOW

K100301 · Ultradent Products, Inc. · Dental
Apr 2010
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K100301 is an FDA 510(k) clearance for the OPAL BOND FLOW, 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 April 29, 2010, 85 days after receiving the submission on February 3, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K100301 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2010
Decision Date April 29, 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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