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iSy® Implants Set 4x
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref P1410.3809
by ALTATEC GmbH
Identity
- Trade Name
- iSy® Implants Set 4x EUDAMEDiSy® Implants-Set FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- iSy® Implant set EUDAMEDP1410.3809 iSy® Implants-Set, 4 units d 3.8 mm, L 9 mm FDA UDI
- Model / Reference
- P1410.3809 EUDAMEDFDA UDI
- Description
- P1410.3809 iSy® Implants-Set, 4 units d 3.8 mm, L 9 mm FDA UDI
Identifiers
- Catalog Number
- P1410.3809 FDA UDI
- Primary DI / UDI-DI
- 04099797020359 EUDAMEDE219P141038091 FDA UDI
- Basic UDI-DI
- 40997970000601000000000DU EUDAMED
- Secondary DI
- E219P141038091 EUDAMED
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 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
Yes
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
Dimensions & Sizes
- Size
- Length — 9 Millimeter FDA UDI
iSy® Implants Set 4x 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 | 40997970000601000000000DU | 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 b38c229d-7067-4d5f-9afb-53bdfc215d95 61 fields · synced Jun 18, 2026
- FDA UDI 1d444400-f867-4795-ba6a-c9dc00e49b1f 36 fields · synced May 30, 2026