Cleared Special

ELATION MB METAL REINFORCED PLASTIC BRACKET (K092030) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K092030 · Dentsply Interntional · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
18d
Days
Class 2
Risk

K092030 is an FDA 510(k) clearance for the ELATION MB METAL REINFORCED PLASTIC BRACKET. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Dentsply Interntional (York, US). The FDA issued a Cleared decision on July 24, 2009 after a review of 18 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.

View all Dentsply Interntional devices

Submission Details

510(k) Number K092030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2009
Decision Date July 24, 2009
Days to Decision 18 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 127d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 41
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