Identity
- Trade Name
- IS Abutment Screw EUDAMEDNeobiotech Implant System FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- Dental Surgical Instrument EUDAMEDM1.6 FDA UDI
- Model / Reference
- ISCS20G EUDAMEDISCS16S EUDAMEDFDA UDI
- Description
- M1.6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809876904786 EUDAMED08809486296882 EUDAMEDFDA UDI
- Basic UDI-DI
- 880927676NBRSIRSCL1S03FT EUDAMEDB-08809486296882 EUDAMED
- 510(k) Number
- K190849 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMEDP01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDEUDAMEDFDA UDI
Reusable
Yes
EUDAMEDEUDAMED
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
IS Abutment Screw by Neobiotech Co., Ltd. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 880927676NBRSIRSCL1S03FT | Class I | Active |
| EUDAMED | European Union | CE/MDR | 880927676NBRSIRSCL1S03FT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neobiotech Co., Ltd.
- EUDAMED SRN
- KR-MF-000016946
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 766bec61-6630-4edd-b754-6329d50d919d 61 fields · synced Aug 3, 2026
- FDA UDI 6a0c1895-a541-4915-ae17-e837825da397 34 fields · synced May 30, 2026
- EUDAMED ee934c80-ebfb-484e-859b-4f10feb579ce 61 fields · synced Aug 3, 2026