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iSy® Plastic coping
EUDAMEDFDA UDIClass I (EU MDR)
Ref P2553.0025
by ALTATEC GmbH
Identity
- Trade Name
- iSy® Plastic coping EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- iSy® Plastic coping EUDAMEDiSy® Plastic coping cemented hybrid abutment FDA UDI
- Model / Reference
- P2553.0025 EUDAMEDFDA UDI
- Description
- iSy® Plastic coping cemented hybrid abutment FDA UDI
Identifiers
- Catalog Number
- P2553.0025 FDA UDI
- Primary DI / UDI-DI
- 04099797021295 EUDAMEDE219P255300251 FDA UDI
- Basic UDI-DI
- 40997970008013000000000KX EUDAMED
- Secondary DI
- E219P255300251 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
iSy® Plastic coping by ALTATEC GmbH — Class I — 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 | 40997970008013000000000KX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (2)
- EUDAMED 5232f32f-ba2a-4188-9aba-de2427ad7d9b 61 fields · synced Jul 21, 2026
- FDA UDI bef2246c-70ce-4c91-b95b-8270183dc8f5 35 fields · synced May 29, 2026