Cleared Special

K130643 - ACCELEDENT AURA

K130643 is an FDA 510(k) clearance for ACCELEDENT AURA, manufactured by Orthoaccel Technologies, Inc.. The device is a Class 2 Dental device with product code OYH cleared through the Special 510(k) pathway after a 43-day FDA review.

K130643 · Orthoaccel Technologies, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
43d
Days
Class 2
Risk

K130643 is an FDA 510(k) clearance for the ACCELEDENT AURA. Classified as Orthodontic Vibratory Accessory (product code OYH), Class II - Special Controls.

Submitted by Orthoaccel Technologies, Inc. (Bellaire, US). The FDA issued a Cleared decision on April 23, 2013 after a review of 43 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 - K130643

510(k) Number K130643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2013
Decision Date April 23, 2013
Days to Decision 43 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
85d faster than avg
Panel avg: 128d · This submission: 43d
Pathway characteristics
Modification to existing cleared device.

OYH Device Classification - Class 2, Special Controls

Product Code OYH Orthodontic Vibratory Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition An Orthodontic Accessory Intended For Use During Orthodontic Treatment. It Is Used In Conjunction With Orthodontic Appliances Such As Braces And Helps Facilitate Minor Anterior Tooth Movement.
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.

K130643 · ACCELEDENT AURA
Download PDF FDA Summary Orthoaccel Technologi…