Neoss Implant System
FDA UDIEUDAMEDClass I (US FDA UDI)
by Neoss, Ltd.
Identity
- Trade Name
- Drill Kit, Straight – Short 7-13mm EUDAMEDNeoss Implant System FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Reusable Drill EUDAMEDDrill Kit, Straight – Short 7-13mm FDA UDI
- Model / Reference
- 41184 EUDAMEDFDA UDI
- Description
- Drill Kit, Straight – Short 7-13mm FDA UDI
Identifiers
- Catalog Number
- 41184 FDA UDI
- Primary DI / UDI-DI
- 05060440332135 EUDAMEDFDA UDI
- Basic UDI-DI
- 506044033N0016MY EUDAMED
- Direct Marketing DI
- 05060440332135 EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Fixture/appliance dental drill bit, reusable
Neoss Implant System by Neoss, Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Fixture/appliance dental drill bit, reusable.
- Hahn — PRISMATIK DENTALCRAFT, INC. · Class I
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
- Bone Compaction Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Prima Plus — Keystone Dental Inc. · Class I
- FTN Tapered Drill — DIO Corporation · Class I
- Prima — Keystone Dental Inc. · Class I
- Twist Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Stopper Drill — Megagen Implant Co. Ltd · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neoss, Ltd.
Sources (2)
- FDA UDI aea8aceb-59c9-4e35-9946-5764f16bd820 35 fields · synced Jun 18, 2026
- EUDAMED 1aa2fffd-8cb5-4030-b4a0-28f20cd223ec 61 fields · synced Jun 18, 2026