Identity
- Trade Name
- InvivoDental FDA UDI
- Generic Name
- Radiology information system application software FDA UDI
- Device Name
- InVivoDental EUDAMED3D imaging application specialized in dental and medical applications such as implantology, orthodontics, oral surgery, and restorative. FDA UDI
- Model / Reference
- 7 EUDAMEDSW-INV-7.0 EUDAMED7.0 FDA UDI
- Description
- 3D imaging application specialized in dental and medical applications such as implantology, orthodontics, oral surgery, and restorative. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852060007242 EUDAMEDFDA UDI
- Basic UDI-DI
- 0852060007InVivoDental6B9 EUDAMED
- Direct Marketing DI
- 00852060007242 EUDAMED
- 510(k) Number
- K123519 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z12040182 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiology information system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
InVivoDental by Anatomage, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0852060007InVivoDental6B9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Anatomage, Inc.
- EUDAMED SRN
- US-MF-000027423
- Authorised Representative
- Freyr Regulatory GmbH DE-AR-000047121
Sources (2)
- EUDAMED fc70dee8-04be-4127-becb-18d6563e50e0 61 fields · synced Jul 14, 2026
- FDA UDI 9d782447-b75a-4a6f-a101-8b53f8723b93 34 fields · synced May 30, 2026