Cleared Traditional

K232429 - Titan Dental Design (FDA 510(k) Clearance)

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

K232429 · Clearadvance, LLC · Dental device
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Optimized for regulatory review, auditing and printing
Oct 2023
Decision
63d
Days
Class 2
Risk

K232429 is an FDA 510(k) clearance for the Titan Dental Design. Classified as Orthodontic Software (product code PNN), Class II - Special Controls.

Submitted by Clearadvance, LLC (Irvine, US). The FDA issued a Cleared decision on October 13, 2023 after a review of 63 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 Clearadvance, LLC devices

Submission Details

510(k) Number K232429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2023
Decision Date October 13, 2023
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PNN Orthodontic Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Is Software That Is To Be Used For The Diagnosis And Treatment Planning Of Orthodontic Patients And Conditions. It May Include Orthodontic Output Devices Used For The Treatment Of Orthodontics. The Device Is Intended For Prescription Use Only.
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 - PNN Orthodontic Software

All 32
Devices cleared under the same product code (PNN) and FDA review panel - the closest regulatory comparables to K232429.
SureSmile Software
K253565 · Dentsply Sirona, Inc. · Mar 2026
SmileInspector
K252507 · Amv Consulting, LLC · Jan 2026
Celebrace Software
K253343 · Celebrace · Dec 2025
Laon Ortho
K250198 · Laon Medi, Inc. · Apr 2025
Progressive Orthodontics App
K241153 · Progressive Aligners, Inc. · Oct 2024
RAYDENT SW
K233625 · Ray Co., Ltd. · May 2024