Identity
- Trade Name
- FastMap FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, laboratory FDA UDI
- Device Name
- FASTMAP USER MANUAL, ENGLISH FDA UDI
- Model / Reference
- P012003 FDA UDI
- Description
- FASTMAP USER MANUAL, ENGLISH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817421022883 FDA UDI
- FDA Product Code
- NOF FDA UDI
- GMDN Term
- Dental milling system, CAD/CAM, laboratory 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental milling system, CAD/CAM, laboratory
FastMap by X-Nav Technologies, LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- X-Nav Technologies, LLC
Sources (2)
- FDA UDI c67dd348-ae59-4ad1-ad75-83cc1b89834e 33 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 1, 2026