FDA UDI In Commercial Distribution 🇺🇸 United States

Automate

DI: 05902729753821 · Model: R1.2 · 3shape A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Automate
Primary DI
05902729753821
Version / Model
R1.2
Company Name
3shape A/S
Labeler DUNS
306826012
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-03-28
Public Version
1
Public Version Date
2023-04-05
Public Version Status
New
Public Device Record Key
9f225a41-25a0-4654-8f34-248b71416f89

Device Description

The 3Shape Automate software is a web service for automatic design of crowns

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
PNN Orthodontic Software

GMDN Terms

Code Name
60883 Dental treatment application software

Identifiers

Type ID
Primary 05902729753821