Cleared Traditional

K032042 - ENVISION

K032042 is the FDA 510(k) clearance for ENVISION by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

K032042 is an FDA 510(k) clearance for the ENVISION. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on September 29, 2003 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Sybron Dental Specialties, Inc. devices

Submission Details

510(k) Number K032042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 72
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K032042.
AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE
K040548 · Harry J. Bosworth Co. · Mar 2004
IDEAL 1 ORTHODONTIC BRACKET ADHESIVE
K033703 · Dentsply Intl. · Feb 2004
OPTIBAND LC
K032407 · Sybron Dental Specialties, Inc. · Oct 2003
SOLO ORTHO 3
K020502 · Sybron Dental Specialties, Inc. · May 2002
GC FUJI ORTHO BAND PASTE PAK
K020578 · GC America, Inc. · Apr 2002
PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
K014133 · Pulpdent Corp. · Mar 2002