Cleared Traditional

K110335 - CERAMIC BRACKETS

K110335 is an FDA 510(k) clearance for CERAMIC BRACKETS, manufactured by Ortho Organizers, Inc.. The device is a Class 2 Dental device with product code NJM cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K110335 · Ortho Organizers, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
104d
Days
Class 2
Risk

K110335 is an FDA 510(k) clearance for the CERAMIC BRACKETS. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Ortho Organizers, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 19, 2011 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ortho Organizers, Inc. devices

FDA 510(k) Submission Details - K110335

510(k) Number K110335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2011
Decision Date May 19, 2011
Days to Decision 104 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 127d · This submission: 104d
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 K110335.
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RADIANCE
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