Cleared Traditional

IDEAL 1 ORTHODONTIC BRACKET ADHESIVE

K033703 · Dentsply Intl. · Dental
Feb 2004
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K033703 is an FDA 510(k) clearance for the IDEAL 1 ORTHODONTIC BRACKET ADHESIVE, a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on February 6, 2004, 73 days after receiving the submission on November 25, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K033703 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2003
Decision Date February 06, 2004
Days to Decision 73 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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