Cleared Traditional

K122753 - EMPOWER CLEAR

K122753 is an FDA 510(k) clearance for EMPOWER CLEAR, manufactured by American Orthodontics. The device is a Class 2 Dental device with product code NJM cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K122753 · American Orthodontics · Dental device
Download Printable Device Report (PDF)
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Dec 2012
Decision
98d
Days
Class 2
Risk

K122753 is an FDA 510(k) clearance for the EMPOWER CLEAR. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on December 14, 2012 after a review of 98 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 American Orthodontics devices

FDA 510(k) Submission Details - K122753

510(k) Number K122753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2012
Decision Date December 14, 2012
Days to Decision 98 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
29d faster than avg
Panel avg: 127d · This submission: 98d
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 45
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K122753.
EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS
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ORTHODONTIC CERAMIC BRACKETS
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K113334 · Opal Orthodontics by Ultradent Products, Inc. · Feb 2012