Cleared Special

EVOLVE (K033551) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033551 · Reliance Orthodontic Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
36d
Days
Class 2
Risk

K033551 is an FDA 510(k) clearance for the EVOLVE. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Reliance Orthodontic Products, Inc. (Schaumburg, US). The FDA issued a Cleared decision on December 16, 2003 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Reliance Orthodontic Products, Inc. devices

Submission Details

510(k) Number K033551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2003
Decision Date December 16, 2003
Days to Decision 36 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 127d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

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 23
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K033551.
LC BRACKET ADHESIVE SYSTEM
K050750 · Dentsply Intl. · Apr 2005
IDEAL 1 ORTHODONTIC BAND CEMENT
K040375 · Dentsply Intl. · Apr 2004
IDEAL 1 ORTHODONTIC BRACKET ADHESIVE
K033703 · Dentsply Intl. · Feb 2004
ACCLAIM* BRACKET ADHESIVE
K864008 · Johnson & Johnson Professionals, Inc. · Oct 1986
EXCEL BRACKET ADHESIVE
K854050 · Johnson & Johnson Professionals, Inc. · Nov 1985
VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE
K853523 · Dentsply Intl. · Nov 1985