Cleared Traditional

K171860 - Sureclear aligners

K171860 is an FDA 510(k) clearance for Sureclear aligners, manufactured by Emergo Global Consulting, LLC. The device is a Class 2 Dental device with product code NXC cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K171860 · Emergo Global Consulting, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
197d
Days
Class 2
Risk

K171860 is an FDA 510(k) clearance for the Sureclear aligners. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Emergo Global Consulting, LLC (Austin, US). The FDA issued a Cleared decision on January 5, 2018 after a review of 197 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.

View all Emergo Global Consulting, LLC devices

FDA 510(k) Submission Details - K171860

510(k) Number K171860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2017
Decision Date January 05, 2018
Days to Decision 197 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
70d slower than avg
Panel avg: 127d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

NXC Device Classification - Class 2, Special Controls

Product Code NXC Aligner, Sequential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.
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

Regulatory Technology Services, LLC
MARK JOB

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 - NXC Aligner, Sequential

All 127
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K171860.
Custom Clear Aligner System
K173785 · Derby Dental Laboratory · Mar 2018
Blue Sky Bio Aligner
K180107 · Blue Sky Bio, LLC · Feb 2018
Angel Align System
K171674 · Smile Development Corp · Jan 2018
MTM Clear Aligner
K163155 · Dentsply Sirona · Feb 2017
MTM(R) CLEAR ALIGNER
K132145 · Dentsply International, Inc. · Oct 2013
MTM CLEAR ALIGNER IN-OFFICE
K123925 · Dentsply International, Inc. · May 2013