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iSy® Scan adapter
EUDAMEDFDA UDIClass I (EU MDR)
Ref P2620.0007
by ALTATEC GmbH
Identity
- Trade Name
- iSy® Scan adapter EUDAMEDiSy® Scan adapter for Sirona FDA UDI
- Generic Name
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
- Device Name
- iSy® Instruments for impression taking EUDAMEDiSy® Scan adapter for Sirona FDA UDI
- Model / Reference
- P2620.0007 EUDAMEDFDA UDI
- Description
- iSy® Scan adapter for Sirona FDA UDI
Identifiers
- Catalog Number
- P2620.0007 FDA UDI
- Primary DI / UDI-DI
- 04099797021325 EUDAMEDE219P262000071 FDA UDI
- Basic UDI-DI
- 40997970008121000000000L9 EUDAMED
- Secondary DI
- E219P262000071 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant abutment analog, intraoral-scanning, 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® Scan adapter 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
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40997970008121000000000L9 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 40997970008121000000000L9 | 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 (2)
- EUDAMED 231783ce-19c5-4526-8051-8e14b32e4b4f 61 fields · synced May 31, 2026
- FDA UDI 4fba5d41-ebc1-4e76-85c4-1eb6bf046627 35 fields · synced May 29, 2026