Cleared Traditional

K201036 - PlaniMax Orthodontic Software

K201036 is an FDA 510(k) clearance for PlaniMax Orthodontic Software, manufactured by Choice Biotech, Inc.. The device is a Class 2 Dental device with product code PNN cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K201036 · Choice Biotech, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2020
Decision
246d
Days
Class 2
Risk

K201036 is an FDA 510(k) clearance for the PlaniMax Orthodontic Software. Classified as Orthodontic Software (product code PNN), Class II - Special Controls.

Submitted by Choice Biotech, Inc. (Tainan City, TW). The FDA issued a Cleared decision on December 22, 2020 after a review of 246 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 Choice Biotech, Inc. devices

FDA 510(k) Submission Details - K201036

510(k) Number K201036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2020
Decision Date December 22, 2020
Days to Decision 246 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
119d slower than avg
Panel avg: 127d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PNN Device Classification - Class 2, Special Controls

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 Peers - PNN Orthodontic Software

All 30
Devices cleared under the same product code (PNN) and FDA review panel - the closest regulatory comparables to K201036.
ArchForm Orthodontic Software System
K213916 · Archform, Inc. · Dec 2021
BRIUS Planner Software
K212828 · Brius Technologies, Inc. · Oct 2021
Inbrace Orthodontic System
K203442 · Swift Health Systems, Inc. · Feb 2021
AUTOLIGN
K192847 · Diorco Co., Ltd. · Jul 2020
ULab Systems uDesign Software
K200772 · Ulab Systems, Inc. · Jun 2020
NemoCast
K193003 · Software Nemotec S.L. · Jun 2020