Identity
- Trade Name
- infinity OCTAGON TL RP Healing abutment GH 4.5 mm FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Healing abutment GH 4.5 mm for infinity OCTAGON Dental Implant TL RP FDA UDI
- Model / Reference
- 5035751 FDA UDI
- Description
- Healing abutment GH 4.5 mm for infinity OCTAGON Dental Implant TL RP FDA UDI
Identifiers
- Catalog Number
- 5035751 FDA UDI
- Primary DI / UDI-DI
- E0HM50357511 FDA UDI
- 510(k) Number
- K122807 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
infinity OCTAGON TL RP Healing abutment GH 4.5 mm by Hager & Meisinger Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID
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 |
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Manufacturer
Sources (1)
- FDA UDI 43b0c3e9-6dda-4c76-b6fa-995c0a2f5468 37 fields · synced Jun 1, 2026