Identity
- Trade Name
- Disposable Sleeve Primescan (50 pcs.) FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Model / Reference
- 6686880 FDA UDI
Identifiers
- Primary DI / UDI-DI
- E27666868800 FDA UDI
- FDA Product Code
- NOF FDA UDI
- GMDN Term
- Dental milling system, CAD/CAM, chairside FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental milling system, CAD/CAM, chairside
Disposable Sleeve Primescan (50 pcs.) by Sirona Dental Systems GmbH — 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
- Sirona Dental Systems GmbH
Sources (1)
- FDA UDI ce685fe6-1f39-484f-b624-a540625100bb 33 fields · synced Jun 6, 2026