Identity
- Trade Name
- OT-F2 Prosthetics FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- 4plus6Line Abutment System, Angle: 0°, made by Titanium, Diameter: 4,1mm, Gingival height: 1,5mm FDA UDI
- Model / Reference
- 02-4419014510 FDA UDI
- Description
- 4plus6Line Abutment System, Angle: 0°, made by Titanium, Diameter: 4,1mm, Gingival height: 1,5mm FDA UDI
Identifiers
- Catalog Number
- 02-4419014510 FDA UDI
- Primary DI / UDI-DI
- EOTM0244190145101 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Screw endosteal dental implant, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Screw endosteal dental implant, one-piece
OT-F2 Prosthetics by OT medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Screw endosteal dental implant, one-piece.
- Infinity External Hex System — ACE SURGICAL SUPPLY CO., INC. · Class II
- KJ Mini Implant System — Kj Meditech · Class II
- VERSALIS S PLUS — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
- Zirlux — HENRY SCHEIN, INC. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- Tryon — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
- KJ Mini Implant System — Kj Meditech · Class II
- Advanced Intermezzo Fixture — Megagen Implant Co. Ltd · Class II
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
- OT medical GmbH
Sources (1)
- FDA UDI 93f2f0c8-bd56-4697-9b3e-2df0c7aa39ef 34 fields · synced May 29, 2026