Cleared Traditional

OPTIBAND LC

K032407 · Sybron Dental Specialties, Inc. · Dental
Oct 2003
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K032407 is an FDA 510(k) clearance for the OPTIBAND LC, a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH), submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on October 6, 2003, 63 days after receiving the submission on August 4, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K032407 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2003
Decision Date October 06, 2003
Days to Decision 63 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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