← Back to catalogue
iSy® Impression post
EUDAMEDFDA UDIClass I (EU MDR)
Ref P2110.4400
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, closed tray EUDAMEDiSy® Impression post closed tray, d= M FDA UDI
- Model / Reference
- P2110.4400 EUDAMEDFDA UDI
- Description
- iSy® Impression post closed tray, d= M FDA UDI
Identifiers
- Catalog Number
- P2110.4400 FDA UDI
- Primary DI / UDI-DI
- 04099797020632 EUDAMEDE219P211044001 FDA UDI
- Basic UDI-DI
- 40997970008120000000000KC EUDAMED
- Secondary DI
- E219P211044001 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 | 40997970008120000000000KC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 01fdd35b-3ce7-4bdb-9422-f7e167e18d91 61 fields · synced Jul 20, 2026
- FDA UDI 54bd9be1-74d4-46fa-835d-3641425286d6 35 fields · synced May 30, 2026