Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Diagnostic-imaging multiformat camera FDA UDI
- Device Name
- Camera alone (without Box and accessories) "In mode I, diagnosis aid mode, SOPROLIFE helps the dental practitioner to detect damage at various clinical stages in very high resolution. In mode II, treatment aid mode, SOPROLIFE helps dental practitioner to get a spatial map of unbroken tissue areas which are suspect. In daylight mode », SOPROLIFE enables you to visualize anatomical details invisible to the naked eye or with a mirror. It allows the dentist to show the difference between «before» and «after» care." FDA UDI
- Model / Reference
- SOPROLIFE NTSC FDA UDI
- Description
- Camera alone (without Box and accessories) "In mode I, diagnosis aid mode, SOPROLIFE helps the dental practitioner to detect damage at various clinical stages in very high resolution. In mode II, treatment aid mode, SOPROLIFE helps dental practitioner to get a spatial map of unbroken tissue areas which are suspect. In daylight mode », SOPROLIFE enables you to visualize anatomical details invisible to the naked eye or with a mirror. It allows the dentist to show the difference between «before» and «after» care." FDA UDI
Identifiers
- Catalog Number
- 997043 FDA UDI
- Primary DI / UDI-DI
- 03760278260304 FDA UDI
- FDA Product Code
- NBL FDA UDI
- GMDN Term
- Diagnostic-imaging multiformat camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1745 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Diagnostic-imaging multiformat camera
Acteon by Sopro — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Sopro
Sources (1)
- FDA UDI 1fedfa65-d14d-4d5c-8608-005d138c59dc 35 fields · synced Jun 8, 2026