Device
Laon Ortho is a PC-based software that sets up virtual orthodontics via digital impressions. It automatically segments the crown and the gum in a simple manner and provides basic m...
Manufacturer
Laon Medi Inc.
Laon Medi Inc.
Model: 2.0
DI: 08800130800080
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
Laon Ortho is a PC-based software that sets up virtual orthodontics via digital impressions. It automatically segments the crown and the gum in a simple manner and provides basic model analysis to assist digital orthodontic procedures.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7d00d72b-8327-45a8-92bd-b51e030a2678
Distribution Status:
In Commercial Distribution
DUNS Number:
695282782
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08800130800080
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 50484
Name: CAD/CAM software
Definition:
A software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals.
FDA Product Codes
LLZ
System, Image Processing, Radiological
Premarket Submissions
Submission Number:
K250198
Supplement Number:
000