Cleared Traditional

IDEAL 1 ORTHODONTIC BAND CEMENT

K040375 · Dentsply Intl. · Dental
Apr 2004
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K040375 is an FDA 510(k) clearance for the IDEAL 1 ORTHODONTIC BAND CEMENT, 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 April 2, 2004, 45 days after receiving the submission on February 17, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K040375 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 2004
Decision Date April 02, 2004
Days to Decision 45 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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