Cleared Traditional

Orthodontic Appliance (K181747) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181747 · Shandong Huge Dental Material Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
290d
Days
Class 2
Risk

K181747 is an FDA 510(k) clearance for the Orthodontic Appliance. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Shandong Huge Dental Material Corporation (Rizhao City, CN). The FDA issued a Cleared decision on April 18, 2019 after a review of 290 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 Shandong Huge Dental Material Corporation devices

Submission Details

510(k) Number K181747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2018
Decision Date April 18, 2019
Days to Decision 290 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
163d slower than avg
Panel avg: 127d · This submission: 290d
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 Peers - NXC Aligner, Sequential

All 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K181747.
Bioliner
K182658 · Five Star Orthodontic Lab & Supply · Jun 2019
Argen Clear Aligner
K183229 · Argen Corporation · Jun 2019
Magic Clear Aligners
K190948 · Voodoo Manufacturing, Inc. · May 2019
Byte Aligner System
K180346 · Straight Smile, LLC · Feb 2019
Park Dental Research Aligners
K180648 · Park Dental Research Corporation · Jan 2019
Clear Image Aligners
K183643 · Specialty Appliance Works, Inc. · Jan 2019