Cleared Traditional

K131197 - EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS

K131197 is an FDA 510(k) clearance for EDGEWISE CERAMIC BRACKETS, manufactured by Dental Morelli. The device is a Class 2 Dental device with product code NJM cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K131197 · Dental Morelli · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
123d
Days
Class 2
Risk

K131197 is an FDA 510(k) clearance for the EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Dental Morelli (Aventura, US). The FDA issued a Cleared decision on August 27, 2013 after a review of 123 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.

FDA 510(k) Submission Details - K131197

510(k) Number K131197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2013
Decision Date August 27, 2013
Days to Decision 123 days
Submission Type Traditional
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
5d faster than avg
Panel avg: 128d · This submission: 123d
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 58
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K131197.
Chi Lites Orthodontic Sapphire Bracket
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CERAMIN BRACKETS Z
K123092 · Tomy, Inc. · Dec 2012
EMPOWER CLEAR
K122753 · American Orthodontics · Dec 2012