Identity
- Trade Name
- InVivoDental EUDAMEDFDA 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 EUDAMEDSWPG-INV-65 EUDAMED6.0 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
- 00852060007006 EUDAMEDFDA UDI
- Basic UDI-DI
- 0852060007InVivoDental6B9 EUDAMED
- Direct Marketing DI
- 00852060007006 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
- France 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 — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123519 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K070803 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0852060007InVivoDental6B9 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Anatomage, Inc.
- EUDAMED SRN
- US-MF-000027423
- Authorised Representative
- Freyr Regulatory GmbH DE-AR-000047121
Sources (3)
- EUDAMED 6fe59d6e-49b1-4450-aff3-51ac43b0254a 61 fields · synced Jul 16, 2026
- FDA UDI 89b45fb7-40cc-4737-9b75-792cebf8043b 34 fields · synced May 30, 2026
- FDA 510(k) K123519 1 fields · synced May 18, 2026