FDA UDI
Not in Commercial Distribution
🇺🇸 United States
3Shape Anatomy Design
DI: 05902768365115
·
Model: 2016-1
·
3shape A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3Shape Anatomy Design
- Primary DI
- 05902768365115
- Version / Model
- 2016-1
- Company Name
- 3shape A/S
- Labeler DUNS
- 306826012
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-25
- Public Version
- 4
- Public Version Date
- 2023-02-24
- Public Version Status
- Update
- Public Device Record Key
- 3186bd2f-0fb6-49fb-9b2e-90cbd5a14791
- Distribution End Date
- 2023-02-01
Device Description
The Anatomy Design software is intended to be used for designing dental restorations for use by dentists for patients.The Anatomy Design software can be operated by trained dental practitioners and dental technicians.The Anatomy Design software is to be used in standard dentist clinics and dental laboratories
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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Dental | 872.3661 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50484 | CAD/CAM software | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05902768365115 | GS1 |
Customer Contacts
- Phone
- +4570272620
- [email protected]