Identity
- Trade Name
- Automate FDA UDI
- Generic Name
- CAD/CAM software FDA UDI
- Device Name
- Automate is intended to generate design and manufacturing files for dental restorative prosthetics and dental appliances. Automate can be used for the following: - Dental prosthetic restorations - Dental appliances FDA UDI
- Model / Reference
- R2b FDA UDI
- Description
- Automate is intended to generate design and manufacturing files for dental restorative prosthetics and dental appliances. Automate can be used for the following: - Dental prosthetic restorations - Dental appliances FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05902729754019 FDA UDI
- FDA Product Code
- NOF FDA UDI
- GMDN Term
- CAD/CAM software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: CAD/CAM software
Automate by 3shape A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ProPlan CMF — Materialise NV · Class I
- CEREC Guide — Sirona Dental Systems GmbH · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- 3shape A/S
Sources (1)
- FDA UDI 83106480-724c-4313-beb7-368281c72f9a 33 fields · synced Jun 1, 2026