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iSy® Temporary abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref P2239.4800
by ALTATEC GmbH
Identity
- Trade Name
- iSy® Temporary abutment EUDAMEDiSy® Temporary abutment for crowns FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- iSy® Temporary abutment EUDAMEDiSy® Temporary abutment for crowns, d 4.8 mm FDA UDI
- Model / Reference
- P2239.4800 EUDAMEDFDA UDI
- Description
- iSy® Temporary abutment for crowns, d 4.8 mm FDA UDI
Identifiers
- Catalog Number
- P2239.4800 FDA UDI
- Primary DI / UDI-DI
- 04099797020854 EUDAMEDE219P223948001 FDA UDI
- Basic UDI-DI
- 40997970001903000000000LE EUDAMED
- Secondary DI
- E219P223948001 EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class IIb 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
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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
iSy® Temporary abutment by ALTATEC GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40997970001903000000000LE | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 40997970001903000000000LE | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (2)
- EUDAMED 2a8db144-b507-415d-a626-eeb8d1f43293 61 fields · synced May 31, 2026
- FDA UDI f4002ddf-a46e-43b2-8d58-6932887feb1c 35 fields · synced May 27, 2026