Identity
- Trade Name
- iSy® Implants-Set FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- P1210.4411 iSy® Implants-Set, 2 units d 4.4 mm, L11 mm FDA UDI
- Model / Reference
- P1210.4411 FDA UDI
- Description
- P1210.4411 iSy® Implants-Set, 2 units d 4.4 mm, L11 mm FDA UDI
Identifiers
- Catalog Number
- P1210.4411 FDA UDI
- Primary DI / UDI-DI
- E219P121044111 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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 — 11 Millimeter FDA UDI
iSy® Implants-Set by ALTATEC GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ALTATEC GmbH
Sources (1)
- FDA UDI 15d2b747-f75a-4be6-9cb0-ac8820b42735 37 fields · synced Jun 8, 2026