Neoss Implant System
FDA UDIEUDAMEDClass II (US FDA UDI)
by Neoss, Ltd.
Identity
- Trade Name
- Twist Drill Straight Ø3.4 x 7-17 mm EUDAMEDNeoss Implant System FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, single-use FDA UDI
- Device Name
- Single use Drill EUDAMEDTwist Drill, Straight Ø3.4 x 7-17 mm FDA UDI
- Model / Reference
- 41159 EUDAMEDFDA UDI
- Description
- Twist Drill, Straight Ø3.4 x 7-17 mm FDA UDI
Identifiers
- Catalog Number
- 41159 FDA UDI
- Primary DI / UDI-DI
- 05060440331923 EUDAMEDFDA UDI
- Basic UDI-DI
- 506044033N0015MW EUDAMED
- Direct Marketing DI
- 05060440331923 EUDAMED
- FDA Product Code
- DZI 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 II FDA UDI
- Regulation Number
- 872.4120 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Fixture/appliance dental drill bit, single-use
Neoss Implant System by Neoss, Ltd. — Class II — 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Neoss, Ltd.
Sources (2)
- FDA UDI d00d6318-3d0e-4cb4-9f40-ef6fcba5a515 35 fields · synced Jul 19, 2026
- EUDAMED 7d631195-f891-4242-b534-f6f2cc104d50 61 fields · synced Jul 19, 2026