Model: SN3D-AI
DI: 06970163089140
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
218a4d00-1c41-470a-98a4-41b914292a6e
Distribution Status:
In Commercial Distribution
DUNS Number:
529835314
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06970163089140
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
NOF
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations