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Prosthetic screw
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref J4012.1601
by ALTATEC GmbH
Identity
- Trade Name
- Prosthetic screw EUDAMEDProsthetic screw, for bar abutments FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Prosthetic screw, for bar abutment EUDAMEDProsthetic screw, for bar abutments, hex, light blue anodized, (also for Passive-Fit), thread M1.6, titanium alloy FDA UDI
- Model / Reference
- J4012.1601 EUDAMEDFDA UDI
- Description
- Prosthetic screw, for bar abutments, hex, light blue anodized, (also for Passive-Fit), thread M1.6, titanium alloy FDA UDI
Identifiers
- Catalog Number
- J4012.1601 FDA UDI
- Primary DI / UDI-DI
- 04099797004298 EUDAMEDE219J401216011 FDA UDI
- Basic UDI-DI
- 40997970004507000000000P9 EUDAMED
- Secondary DI
- E219J401216011 EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Prosthetic screw by ALTATEC GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40997970004507000000000P9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (2)
- EUDAMED a9c7ce43-9ef6-41a3-8fba-a997bfb0d600 61 fields · synced May 31, 2026
- FDA UDI 10609162-78c6-4e10-b9e6-0a32e8f24828 35 fields · synced May 30, 2026