Cleared Special

K060837 - IN-OVATION C

K060837 is an FDA 510(k) clearance for IN-OVATION C, manufactured by Dentsply International. The device is a Class 2 Dental device with product code NJM cleared through the Special 510(k) pathway after a 13-day FDA review.

K060837 · Dentsply International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
13d
Days
Class 2
Risk

K060837 is an FDA 510(k) clearance for the IN-OVATION C. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Dentsply International (York, US). The FDA issued a Cleared decision on April 10, 2006 after a review of 13 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 International devices

FDA 510(k) Submission Details - K060837

510(k) Number K060837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2006
Decision Date April 10, 2006
Days to Decision 13 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
115d faster than avg
Panel avg: 128d · This submission: 13d
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 57
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K060837.
RADIANCE
K080749 · American Orthodontics · Aug 2008
SAPPHIRE CERAMIC BRACKET
K073045 · Ortho Technology, Inc. · Dec 2007
CLARITY MODIFIED CERAMIC BRACKETS
K062305 · 3M Unitek · Oct 2006
ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS
K052245 · Lar Mfg., LLC · Sep 2005
NEO-CLIP ORTHODONTIC BRACKET ACCESSORY
K042905 · Dentsply Intl. · Nov 2004
ORTHODONTIC CERAMIC BRACKETS
K042178 · Dentsply Intl. · Aug 2004