Neoss Implant System
FDA UDIEUDAMEDClass I (US FDA UDI)
by Neoss, Ltd.
Identity
- Trade Name
- Impression Coping 18 mm and Replica EUDAMEDNeoss Implant System FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Impression EUDAMEDImpression Coping 18 mm and Replica FDA UDI
- Model / Reference
- 31183 EUDAMEDFDA UDI
- Description
- Impression Coping 18 mm and Replica FDA UDI
Identifiers
- Catalog Number
- 31183 FDA UDI
- Primary DI / UDI-DI
- 05060440332326 EUDAMEDFDA UDI
- Basic UDI-DI
- 506044033N0026N3 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, 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
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, temporary, preformed, 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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Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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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 46a313ee-f570-440e-b355-85afe150d1e4 35 fields · synced Jul 9, 2026
- EUDAMED 354aaac7-abdf-407a-9bbd-964f39ef1c41 61 fields · synced Jul 9, 2026