Identity
- Trade Name
- Implant Studio FDA UDI
- Generic Name
- Dental treatment application software FDA UDI
- Device Name
- 3Shape Implant Studio® is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT and optical scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement. Surgical guides and the planned implant position can be exported as 3D models and the guides can be manufactured using said 3D models when used as input to 3D manufacturing systems. FDA UDI
- Model / Reference
- R1.4 FDA UDI
- Description
- 3Shape Implant Studio® is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT and optical scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement. Surgical guides and the planned implant position can be exported as 3D models and the guides can be manufactured using said 3D models when used as input to 3D manufacturing systems. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05902729753845 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Dental treatment application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental treatment application software
Implant Studio by 3shape A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental treatment application software.
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- iChiropro Surgery APP — Bien-Air Dental SA · Class I
- Swissmeda Dental Planning System — Swissmeda AG · Class II
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 6d4a8d29-517e-4b2c-8c12-a328ba7fabb6 33 fields · synced Jun 1, 2026