Cleared Traditional

K062305 - CLARITY MODIFIED CERAMIC BRACKETS

K062305 is an FDA 510(k) clearance for CLARITY MODIFIED CERAMIC BRACKETS, manufactured by 3M Unitek. The device is a Class 2 Dental device with product code NJM cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K062305 · 3M Unitek · Dental device
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Oct 2006
Decision
71d
Days
Class 2
Risk

K062305 is an FDA 510(k) clearance for the CLARITY MODIFIED CERAMIC BRACKETS. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by 3M Unitek (Monrovia, US). The FDA issued a Cleared decision on October 18, 2006 after a review of 71 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 3M Unitek devices

FDA 510(k) Submission Details - K062305

510(k) Number K062305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2006
Decision Date October 18, 2006
Days to Decision 71 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
56d faster than avg
Panel avg: 127d · This submission: 71d
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 26
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K062305.
EMPOWER CLEAR
K122753 · American Orthodontics · Dec 2012
DAMON 4CLEAR
K081415 · Ormco Corp. · Sep 2008
RADIANCE
K080749 · American Orthodontics · Aug 2008
IN-OVATION C
K060837 · Dentsply International · Apr 2006
NEO-CLIP ORTHODONTIC BRACKET ACCESSORY
K042905 · Dentsply Intl. · Nov 2004
ORTHODONTIC CERAMIC BRACKETS
K042178 · Dentsply Intl. · Aug 2004