Cleared Traditional

K032625 - ORTHODONTIC COMPOSITE BRACKET SYSTEM

K032625 is an FDA 510(k) clearance for ORTHODONTIC COMPOSITE BRACKET SYSTEM, manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with product code DYW cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K032625 · Ultradent Products, Inc. · Dental device
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Feb 2004
Decision
184d
Days
Class 2
Risk

K032625 is an FDA 510(k) clearance for the ORTHODONTIC COMPOSITE BRACKET SYSTEM. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 26, 2004 after a review of 184 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - 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 Ultradent Products, Inc. devices

FDA 510(k) Submission Details - K032625

510(k) Number K032625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2003
Decision Date February 26, 2004
Days to Decision 184 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 127d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYW Device Classification - Class 2, Special Controls

Product Code DYW Bracket, Plastic, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
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 - DYW Bracket, Plastic, Orthodontic

All 30
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K032625.
DAMON 3 MODIFIED
K052477 · Ormco Corp. · Nov 2005
CP BRACKET SYSTEM
K052370 · Dentsply International · Nov 2005
MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM
K050730 · Ultradent Products, Inc. · Mar 2005
DAMON FT
K032408 · Sybron Dental Specialties, Inc. · Oct 2003
ORTHODONTIC BRACES
K981433 · Midwest Orthodontic Mfg. · Jun 1998
REFLECTIONS
K973776 · Cdb Corp. · Nov 1997