Cleared Traditional

DAMON FT

K032408 · Sybron Dental Specialties, Inc. · Dental
Oct 2003
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K032408 is an FDA 510(k) clearance for the DAMON FT, a Bracket, Plastic, Orthodontic (Class II — Special Controls, product code DYW), submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on October 15, 2003, 72 days after receiving the submission on August 4, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K032408 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2003
Decision Date October 15, 2003
Days to Decision 72 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DYW — Bracket, Plastic, Orthodontic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5470

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