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iSy® Implant Cover screw
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref P2019.0001
by ALTATEC GmbH
Identity
- Trade Name
- iSy® Implant Cover screw EUDAMEDiSy® Cover screw, FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- iSy® Cover Screw EUDAMEDiSy® Cover screw, for d 3.8/4.4/5.0 mm FDA UDI
- Model / Reference
- P2019.0001 EUDAMEDFDA UDI
- Description
- iSy® Cover screw, for d 3.8/4.4/5.0 mm FDA UDI
Identifiers
- Catalog Number
- P2019.0001 FDA UDI
- Primary DI / UDI-DI
- 04099797020601 EUDAMEDE219P201900011 FDA UDI
- Basic UDI-DI
- 40997970002302000000000DU EUDAMED
- Secondary DI
- E219P201900011 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
iSy® Implant Cover screw 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
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40997970002302000000000DU | 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 6faddf07-2854-47a1-865e-7acdf6b73046 61 fields · synced Jun 17, 2026
- FDA UDI 8d9c8146-000e-451b-a10a-a0a8804f2b7e 35 fields · synced May 30, 2026