Cleared Traditional

K182329 - SureCure Orthodontic Aligner System

K182329 is the FDA 510(k) clearance for SureCure Orthodontic Aligner System by Digital Orthodontic Care. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K182329 · Digital Orthodontic Care · Dental device
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Optimized for regulatory review, auditing and printing
Nov 2018
Decision
72d
Days
Class 2
Risk

K182329 is an FDA 510(k) clearance for the SureCure Orthodontic Aligner System. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Digital Orthodontic Care (Milton, CA). The FDA issued a Cleared decision on November 8, 2018 after a review of 72 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 Digital Orthodontic Care devices

Submission Details

510(k) Number K182329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2018
Decision Date November 08, 2018
Days to Decision 72 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 faster than avg
Panel avg: 127d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Trisler Consulting
Patsy J. Trisler

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 K182329.
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K183159 · 3M Company · Nov 2018
Invisalign System with Mandibular Advancement Feature
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Ormco Spark Aligner System
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Orthocaps Twinaligner
K180241 · Ortho Caps GmbH · Sep 2018