Neoss Implant System
FDA UDIEUDAMEDClass I (US FDA UDI)
by Neoss, Ltd.
Identity
- Trade Name
- Neoss® Guide Kit Ø3.5 - Ø6.0 EUDAMEDNeoss Implant System FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, single-use FDA UDI
- Device Name
- Reusable Drill EUDAMEDNeoss® Guide Kit Ø3.5 – Ø6.0 FDA UDI
- Model / Reference
- 51154 EUDAMEDFDA UDI
- Description
- Neoss® Guide Kit Ø3.5 – Ø6.0 FDA UDI
Identifiers
- Catalog Number
- 51154 FDA UDI
- Primary DI / UDI-DI
- 05060440332951 EUDAMEDFDA UDI
- Basic UDI-DI
- 506044033N0016MY EUDAMED
- Direct Marketing DI
- 05060440332951 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany 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
No
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Fixture/appliance dental drill bit, single-use
Neoss Implant System by Neoss, Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- Neoss, Ltd.
Sources (2)
- FDA UDI 1fcbfe47-a49f-43f9-9270-8d9bad6c6850 35 fields · synced Jul 21, 2026
- EUDAMED 9efb5035-ca4c-4ee9-a8b2-52141efb3281 61 fields · synced Jul 21, 2026