Device
This software can be used with Medit i900 or i900 classic Intraoral scanner.
Manufacturer
Medit Corp.
Medit Corp.
Model: ML-EXP002
DI: 08800026700883
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
This software can be used with Medit i900 or i900 classic Intraoral scanner.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a3c8f34a-22ce-4663-9071-740504a9d018
Distribution Status:
In Commercial Distribution
DUNS Number:
688800085
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
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:
08800026700883
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 38597
Name: Dental milling system, CAD/CAM, chairside
Definition:
An assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for the production of the actual devices to be fitted to the patient.
FDA Product Codes
NOF
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations