Cleared Traditional

ENVISION

K032042 · Sybron Dental Specialties, Inc. · Dental
Sep 2003
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K032042 is an FDA 510(k) clearance for the ENVISION, 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 September 29, 2003, 90 days after receiving the submission on July 1, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K032042 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2003
Decision Date September 29, 2003
Days to Decision 90 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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