Cleared Traditional

K171844 - Inspire ICE aka Inspire ICE Clear Brackets

K171844 is an FDA 510(k) clearance for Inspire ICE aka Inspire ICE Clear Brackets, manufactured by Ormco Corporation. The device is a Class 2 Dental device with product code NJM cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K171844 · Ormco Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
28d
Days
Class 2
Risk

K171844 is an FDA 510(k) clearance for the Inspire ICE aka Inspire ICE Clear Brackets. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Ormco Corporation (Orange, US). The FDA issued a Cleared decision on July 18, 2017 after a review of 28 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ormco Corporation devices

FDA 510(k) Submission Details - K171844

510(k) Number K171844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2017
Decision Date July 18, 2017
Days to Decision 28 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 128d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Third Party Review Group, LLC
DAVE YUNGVIRT

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 57
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K171844.
3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
K180404 · 3M Healthcare · Mar 2018
Carriere SLX 3D Clear
K173440 · Ortho Organizers, Inc. · Mar 2018
Symetri Clear
K172845 · Ormco Corporation · Jan 2018
C-Line Orthodontic Ceramic Bracket
K163467 · Biocetec Co., Ltd. · Jun 2017
Alpha Pure
K163117 · Koroad America · May 2017
CDB Self Ligating Bracket 8F
K160957 · Cdb Corporation · Sep 2016