Identity
- Trade Name
- INTERNA® UNIVERSAL PLATFORM IMPLANT Ø4,25 ↕13 FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Model / Reference
- IIPU4213 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08435389808237 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.25 Millimeter FDA UDILength — 13 Millimeter FDA UDI
Interna® Universal Platform Implant Ø4, 25 ↕13 by Biotechnology Institute Sl — 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
- Biotechnology Institute Sl
Sources (1)
- FDA UDI 560dc2c0-83db-470e-80f2-2a2f1d4a2371 35 fields · synced Jun 8, 2026