Cleared Traditional

OPAL SEAL

K090355 · Ultradent Products, Inc. · Dental
Apr 2009
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K090355 is an FDA 510(k) clearance for the OPAL SEAL, 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, 2009, 77 days after receiving the submission on February 11, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K090355 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2009
Decision Date April 29, 2009
Days to Decision 77 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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