Drill Pilot Unitite Compact Ø4.8/Ø5.8mm
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- DRILL PILOT Ø3.8XØ4.8MM EUDAMEDDRILL PILOT UNITITE COMPACT Ø4.8/Ø5.8MM FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- DRILLS EUDAMEDDRILL PILOT UNITITE COMPACT Ø4.8/Ø5.8MM FDA UDI
- Model / Reference
- FPUC 4858 EUDAMEDFDA UDIDRILLS WITH DLC EUDAMED
- Description
- DRILL PILOT UNITITE COMPACT Ø4.8/Ø5.8MM FDA UDI
Identifiers
- Catalog Number
- FPUC 4858 FDA UDI
- Primary DI / UDI-DI
- 07899995255037 EUDAMEDFDA UDI
- Basic UDI-DI
- 999520000070K3 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Fixture/appliance dental drill bit, reusable
Drill Pilot Unitite Compact Ø4.8/Ø5.8mm by S.I.N. - Sistema DE Implante Nacional S.A. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- S.I.N. - Sistema DE Implante Nacional S.A.
Sources (2)
- FDA UDI 5cd0adba-25b7-4e80-afdc-f4bad5b01726 34 fields · synced Oct 10, 2026
- EUDAMED 2854c398-a70b-4e1a-921e-4b79ce574bb7 61 fields · synced Jun 20, 2026