Cleared Traditional

K112707 - GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM

K112707 is an FDA 510(k) clearance for GENERATION C AESTHETIC SELF-LIGATING BR..., manufactured by Ortho Technology, Inc.. The device is a Class 2 Dental device with product code NJM cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K112707 · Ortho Technology, Inc. · Dental device
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Jan 2012
Decision
116d
Days
Class 2
Risk

K112707 is an FDA 510(k) clearance for the GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Ortho Technology, Inc. (Tampa, US). The FDA issued a Cleared decision on January 13, 2012 after a review of 116 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 Technology, Inc. devices

FDA 510(k) Submission Details - K112707

510(k) Number K112707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2011
Decision Date January 13, 2012
Days to Decision 116 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 127d · This submission: 116d
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 K112707.
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RADIANCE
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IN-OVATION C
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