Cleared Special

LC BRACKET ADHESIVE SYSTEM

K050750 · Dentsply Intl. · Dental
Apr 2005
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K050750 is an FDA 510(k) clearance for the LC BRACKET ADHESIVE SYSTEM, 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 6, 2005, 14 days after receiving the submission on March 23, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K050750 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2005
Decision Date April 06, 2005
Days to Decision 14 days
Submission Type Special
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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