Cleared Traditional

K052370 - CP BRACKET SYSTEM

K052370 is an FDA 510(k) clearance for CP BRACKET SYSTEM, manufactured by Dentsply International. The device is a Class 2 Dental device with product code DYW cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K052370 · Dentsply International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
63d
Days
Class 2
Risk

K052370 is an FDA 510(k) clearance for the CP BRACKET SYSTEM. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Dentsply International (York, US). The FDA issued a Cleared decision on November 1, 2005 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dentsply International devices

FDA 510(k) Submission Details - K052370

510(k) Number K052370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2005
Decision Date November 01, 2005
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
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 21
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K052370.
CLEARARCH
K101676 · Ormco Corp. · Sep 2010
OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802
K071055 · Ultradent Products, Inc. · May 2007
DAMON 3 MODIFIED
K052477 · Ormco Corp. · Nov 2005
MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM
K050730 · Ultradent Products, Inc. · Mar 2005
ORTHODONTIC COMPOSITE BRACKET SYSTEM
K032625 · Ultradent Products, Inc. · Feb 2004
DAMON FT
K032408 · Sybron Dental Specialties, Inc. · Oct 2003