Cleared Traditional

K053055 - ORTHODONTIC POLYMER COMPOSITE BRACKET

K053055 is an FDA 510(k) clearance for ORTHODONTIC POLYMER COMPOSITE BRACKET, manufactured by Gestenco International AB. The device is a Class 2 Dental device with product code DYW cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K053055 · Gestenco International AB · Dental device
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Dec 2005
Decision
52d
Days
Class 2
Risk

K053055 is an FDA 510(k) clearance for the ORTHODONTIC POLYMER COMPOSITE BRACKET. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Gestenco International AB (Goteborg, SE). The FDA issued a Cleared decision on December 22, 2005 after a review of 52 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 Gestenco International AB devices

FDA 510(k) Submission Details - K053055

510(k) Number K053055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2005
Decision Date December 22, 2005
Days to Decision 52 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 127d · This submission: 52d
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 27
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K053055.
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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