Neoss Implant System
FDA UDIEUDAMEDClass I (US FDA UDI)
by Neoss, Ltd.
Identity
- Trade Name
- Neoss® Guide - Guide Key Ø2.2/2.85 EUDAMEDNeoss Implant System FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, single-use FDA UDI
- Device Name
- Guide Key EUDAMEDNeoss® Guide - Guide Key Ø2.2/2.85 FDA UDI
- Model / Reference
- 51165 EUDAMEDFDA UDI
- Description
- Neoss® Guide - Guide Key Ø2.2/2.85 FDA UDI
Identifiers
- Catalog Number
- 51165 FDA UDI
- Primary DI / UDI-DI
- 05060440332760 EUDAMEDFDA UDI
- Basic UDI-DI
- 506044033N0049NF EUDAMED
- Direct Marketing DI
- 05060440332760 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 I EUDAMEDFDA 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
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
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
Similar devices
Also classified as Fixture/appliance dental drill bit, single-use.
- IQ Dental — IQ DENTAL SUPPLY LLC · Class I
- Screw Removal Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Driva™ Gold Series Drills — BIOMET 3I, LLC · Class I
- Trefoil™ — Nobel Biocare AG · Class I
- ELEMENT profile drill — Thommen Medical AG · Class I
- Gates Glidden Drills — TULSA DENTAL PRODUCTS LLC · Class I
- Screw Removal Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Driva™ Gold Series Drills — BIOMET 3I, LLC · 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 6fae4ba7-dde8-48b0-a100-65e7a4452f27 35 fields · synced Jul 15, 2026
- EUDAMED 137cd182-e5db-46cf-830c-06a22ecea9f0 61 fields · synced Jul 15, 2026