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iSy® Impression post
EUDAMEDFDA UDIClass I (EU MDR)
Ref P2121.0001Ref P2121.5000
by ALTATEC GmbH
Identity
- Trade Name
- iSy® Impression post EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- iSy® Impression post, open tray EUDAMEDiSy® Impresion post open tray, d =L FDA UDI
- Model / Reference
- P2121.0001 EUDAMEDP2121.5000 EUDAMEDFDA UDI
- Description
- iSy® Impresion post open tray, d =L FDA UDI
Identifiers
- Catalog Number
- P2121.5000 FDA UDI
- Primary DI / UDI-DI
- 04099797020656 EUDAMED04099797020687 EUDAMEDE219P212150001 FDA UDI
- Basic UDI-DI
- 40997970008124000000000NY EUDAMED
- Secondary DI
- E219P212100011 EUDAMEDE219P212150001 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
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
Moist Heat or Steam Sterilization FDA UDI
iSy® Impression post 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 | 40997970008124000000000NY | 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 (3)
- EUDAMED 07b315ab-e58c-434d-b341-7d3d30c24530 61 fields · synced Jul 22, 2026
- EUDAMED cbc30c68-fcd7-46fd-b762-9b3edfceb44f 61 fields · synced May 18, 2026
- FDA UDI 2b61e64f-0ee2-4fbb-b37c-35d5525e6821 35 fields · synced May 30, 2026