Cleared Traditional

DigiLine Direct Print Aligner System (K233935) - FDA 510(k) Clearance

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

K233935 · Park Dental Research Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
113d
Days
Class 2
Risk

K233935 is an FDA 510(k) clearance for the DigiLine Direct Print Aligner System. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Park Dental Research Corporation (Ardmore, US). The FDA issued a Cleared decision on April 5, 2024 after a review of 113 days - within the typical 510(k) review window.

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 Park Dental Research Corporation devices

Submission Details

510(k) Number K233935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2023
Decision Date April 05, 2024
Days to Decision 113 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
14d faster than avg
Panel avg: 127d · This submission: 113d
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

Prime Path Medtech
Logan Simmons

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 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K233935.
Clear Moves Aligner
K241137 · Clear Moves Aligners · Aug 2024
Alien Aligners
K241187 · Alien Milling Technologies · Jul 2024
Invisalign System
K241412 · Align Technology, Inc. · Jun 2024
Clear Moves Aligners
K240038 · Space Maintainers Laboratories (Sml) · Apr 2024
Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
K232653 · Blue Sky Bio, LLC · Apr 2024
TERA HARZ CLEAR
K240597 · Graphy, Inc. · Mar 2024