Identity
- Trade Name
- NeoGuide Cortical Tap EUDAMEDNeobiotech Implant System FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Ø3.5, Narrow FDA UDI
- Model / Reference
- NGCT35S09 EUDAMEDFDA UDI
- Description
- Ø3.5, Narrow FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809815657971 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809815657971 EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4130 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Fixture/appliance dental drill bit, reusable
Neobiotech Implant System by Neobiotech. co., ltd — 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
- Neobiotech. co., ltd
Sources (2)
- FDA UDI 610c7e5c-8d30-43b3-8bd8-0647235497c5 33 fields · synced Jul 13, 2026
- EUDAMED b4f2d086-461e-4a03-963b-b0fbb58fb821 61 fields · synced Jul 13, 2026