Identity
- Trade Name
- X PRO DISPOSABLE TIP FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- X PRO DISPOSABLE TIP, INTEGRATED BOX OF 25 TIPS FDA UDI
- Model / Reference
- 901107 FDA UDI
- Description
- X PRO DISPOSABLE TIP, INTEGRATED BOX OF 25 TIPS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430035872954 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
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
Yes
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 milling system, CAD/CAM, chairside
X Pro Disposable Tip by PaloDEx Group Oy — 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
- PaloDEx Group Oy
Sources (1)
- FDA UDI 0aa26cb4-baa5-49b2-aea4-e8aa3296960b 33 fields · synced Jun 1, 2026