Cleared Traditional

K182826 - Ormco Spark Aligner System

K182826 is the FDA 510(k) clearance for Ormco Spark Aligner System by Sybron Dental Specialties. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K182826 · Sybron Dental Specialties · Dental device
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Oct 2018
Decision
6d
Days
Class 2
Risk

K182826 is an FDA 510(k) clearance for the Ormco Spark Aligner System. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Sybron Dental Specialties (Orange, US). The FDA issued a Cleared decision on October 11, 2018 after a review of 6 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 Sybron Dental Specialties devices

Submission Details

510(k) Number K182826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2018
Decision Date October 11, 2018
Days to Decision 6 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
121d faster than avg
Panel avg: 127d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 126
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K182826.
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K181739 · Align Technology, Inc. · Oct 2018
Orthocaps Twinaligner
K180241 · Ortho Caps GmbH · Sep 2018
Smylic Invisible Clear Aligners
K173784 · Smylio, Inc. · Aug 2018
Smart Moves Complete
K172765 · Great Lakes Orthodontics, Ltd. · Jun 2018