Cleared Traditional

K113334 - AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS

K113334 is an FDA 510(k) clearance for AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS, manufactured by Opal Orthodontics by Ultradent Products, Inc.. The device is a Class 2 Dental device with product code NJM cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K113334 · Opal Orthodontics by Ultradent Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
81d
Days
Class 2
Risk

K113334 is an FDA 510(k) clearance for the AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Opal Orthodontics by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 3, 2012 after a review of 81 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 Opal Orthodontics by Ultradent Products, Inc. devices

FDA 510(k) Submission Details - K113334

510(k) Number K113334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2011
Decision Date February 03, 2012
Days to Decision 81 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
46d faster than avg
Panel avg: 127d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NJM Device Classification - Class 2, Special Controls

Product Code NJM Bracket, Ceramic, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition An Orthodontic Ceramic Bracket Is A Device Composed Of Ceramic, Which Is Intended To Be Bonded To A Tooth, Upon Which An Orthodontic Wire Is Used To Move The Tooth To A New Position.
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 - NJM Bracket, Ceramic, Orthodontic

All 45
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K113334.
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K111234 · Tp Orthodontics, Inc. · May 2011