Identity
- Trade Name
- Titanium cap EUDAMEDTitanium cap for crown for bar abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Prosthetic Parts EUDAMEDTitanium cap for crown for bar abutment, incl. prosthetic screw, light blue anodized, for bar abutments Ø 3.3/3.8/4.3 mm, titanium alloy FDA UDI
- Model / Reference
- J2259.4301 EUDAMEDFDA UDI
- Description
- Titanium cap for crown for bar abutment, incl. prosthetic screw, light blue anodized, for bar abutments Ø 3.3/3.8/4.3 mm, titanium alloy FDA UDI
Identifiers
- Catalog Number
- J2259.4301 FDA UDI
- Primary DI / UDI-DI
- 04099797003901 EUDAMEDE219J225943011 FDA UDI
- Basic UDI-DI
- 40997970004502000000000JQ EUDAMED
- Secondary DI
- E219J225943011 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
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
Titanium cap 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 | 40997970004502000000000JQ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (2)
- EUDAMED 595d61a9-66a5-4d53-aa8d-e4ce28846473 61 fields · synced Aug 2, 2026
- FDA UDI d368b19e-7666-4905-8f98-2d3fa95cbb0d 35 fields · synced May 25, 2026