Cleared Traditional

K163117 - Alpha Pure

K163117 is an FDA 510(k) clearance for Alpha Pure, manufactured by Koroad America. The device is a Class 2 Dental device with product code NJM cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K163117 · Koroad America · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
183d
Days
Class 2
Risk

K163117 is an FDA 510(k) clearance for the Alpha Pure. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Koroad America (Newport Beach, US). The FDA issued a Cleared decision on May 9, 2017 after a review of 183 days - an extended review cycle.

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 - K163117

510(k) Number K163117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2016
Decision Date May 09, 2017
Days to Decision 183 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
55d slower than avg
Panel avg: 128d · This submission: 183d
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 Consultant

Provision Consulting Group, Inc.
JOYCE BANG

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K163117.
Symetri Clear
K172845 · Ormco Corporation · Jan 2018
Inspire ICE aka Inspire ICE Clear Brackets
K171844 · Ormco Corporation · Jul 2017
C-Line Orthodontic Ceramic Bracket
K163467 · Biocetec Co., Ltd. · Jun 2017
CDB Self Ligating Bracket 8F
K160957 · Cdb Corporation · Sep 2016
ORTHODONTIC CERAMIC BRACKETS 1.1
K160615 · Tomy, Inc. · Aug 2016
BIJOU Orthodontic Ceramic Bracket
K152167 · World Bio Tech Co., Ltd. · May 2016