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X-Ray Planning foil iSy® Implant System
FDA UDIEUDAMEDClass I (US FDA UDI)
by ALTATEC GmbH
Identity
- Trade Name
- X-Ray Planning foil iSy® Implant System FDA UDI
- Generic Name
- Dental implant x-ray template FDA UDI
- Device Name
- X-Ray Planning foil iSy® Implant System FDA UDI
- Model / Reference
- P5300.9010 FDA UDI
- Description
- X-Ray Planning foil iSy® Implant System FDA UDI
Identifiers
- Catalog Number
- P5300.9010 FDA UDI
- Primary DI / UDI-DI
- E219P530090101 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant x-ray template FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
X-Ray Planning foil iSy® Implant System by ALTATEC GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
Sources (2)
- FDA UDI 3d8f1209-c133-424b-9974-c3ca0ac0f3b8 36 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced May 29, 2026