Identity
- Trade Name
- FINAL CONICAL DRILL GLOBAL FDA UDI
- Generic Name
- Dental implant/prosthesis surgical procedure kit FDA UDI
- Device Name
- FINAL CONICAL DRILL GLOBAL D.4.80 H.11.5 MM FDA UDI
- Model / Reference
- FU3-480-115 FDA UDI
- Description
- FINAL CONICAL DRILL GLOBAL D.4.80 H.11.5 MM FDA UDI
Identifiers
- Catalog Number
- FU3-480-115 FDA UDI
- Primary DI / UDI-DI
- D7701011993 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant/prosthesis surgical procedure kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant/prosthesis surgical procedure kit
Final Conical Drill Global by Sweden & Martina Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sweden & Martina Inc
Sources (2)
- FDA UDI 56dc2fbf-c9b6-4f49-a08b-4d28326864fd 35 fields · synced May 30, 2026
- EUDAMED 1 fields · synced May 22, 2026