← Back to catalogue
Neoss Implant System
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 41146
by Neoss, Ltd.
Identity
- Trade Name
- Drill Stop 15 mm Ø2.2, 3.0, 3.4, 3.9 and 4.4 mm EUDAMEDNeoss Implant System FDA UDI
- Generic Name
- Dental instrument depth limiter FDA UDI
- Device Name
- Drill Stop EUDAMEDDrill Stop 15 mm Ø2.2, 3.0, 3.4, 3.9 and 4.4 mm FDA UDI
- Model / Reference
- 41146 EUDAMEDFDA UDI
- Description
- Drill Stop 15 mm Ø2.2, 3.0, 3.4, 3.9 and 4.4 mm FDA UDI
Identifiers
- Catalog Number
- 41146 FDA UDI
- Primary DI / UDI-DI
- 05060440331855 EUDAMEDFDA UDI
- Basic UDI-DI
- 506044033N0044N5 EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental instrument depth limiter 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental instrument depth limiter
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 Dental instrument depth limiter.
- DIO Sinus Approach Stopper — DIO Corporation · Class I
- DIO Sinus Approach Stopper — DIO Corporation · Class I
- DIO Guide Sinus Approach Stopper — DIO Corporation · Class I
- DIO Guide Sinus Approach Stopper — DIO Corporation · Class I
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC. · Class I
- DIO Drill Stopper — DIO Corporation · Class I
- DIO Guide Sinus Approach Stopper — DIO Corporation · Class I
- DIO Guide Sinus Approach Stopper — DIO Corporation · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 afa026b4-2eca-4355-81b6-b64b9d04887e 35 fields · synced Jul 25, 2026
- EUDAMED b088e077-e7e2-4e4d-926d-a081e397e14e 61 fields · synced Jul 25, 2026