Cleared Special

K090454 - ALLURE MB CERAMIC BRACKETS

K090454 is an FDA 510(k) clearance for ALLURE MB CERAMIC BRACKETS, manufactured by Dentsply Interntional. The device is a Class 2 Dental device with product code NJM cleared through the Special 510(k) pathway after a 25-day FDA review.

K090454 · Dentsply Interntional · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
25d
Days
Class 2
Risk

K090454 is an FDA 510(k) clearance for the ALLURE MB CERAMIC BRACKETS. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Dentsply Interntional (York, US). The FDA issued a Cleared decision on March 20, 2009 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K090454

510(k) Number K090454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2009
Decision Date March 20, 2009
Days to Decision 25 days
Submission Type Special
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
103d faster than avg
Panel avg: 128d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 59
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K090454.
CDB FLIP-SIDE-CLIP BRACKET
K091702 · Cdb Corporation · Aug 2009
BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS
K090933 · Forestadent Bernhard Forster GmbH · Jun 2009
ORTHODONTIC CERAMIC BRACKET
K090567 · Star Dentech Korea., Corp · May 2009
MYSTIQUE MB CERAMIC BRACKETS
K082974 · Dentsply Interntional · Nov 2008
CDB CLIP
K080906 · Cdb Corporation · Oct 2008
DAMON 4CLEAR
K081415 · Ormco Corp. · Sep 2008
K090454 · ALLURE MB CERAMIC BRACKETS
Download PDF FDA Summary Dentsply Interntional