Identity
- Trade Name
- KJ Mini Implant System FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- KJ Mini Implant System/Ball Fixture FDA UDI
- Model / Reference
- MIBS2511-18 FDA UDI
- Description
- KJ Mini Implant System/Ball Fixture FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809702405524 FDA UDI
- 510(k) Number
- K151970 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Category: Screw endosteal dental implant, one-piece
The KJ Mini Implant System/Ball Fixture is a sterile, one-piece device made of alloplastic materials intended to provide support and retention for dental prosthesis. It is designed for implantation into alveolar and/or basal bone of the mandible or maxilla.
Similar devices
Also classified as Screw endosteal dental implant, one-piece.
- Infinity External Hex System — ACE SURGICAL SUPPLY CO., INC. · 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
- Advanced Intermezzo Fixture — Megagen Implant Co. Ltd · Class II
- OT-F2 Prosthetics — OT medical GmbH · Class II
- Zirlux — HENRY SCHEIN, INC. · Class II
Cleared under the same submission
K151970 also covers:
- KJ Mini Implant System — Kj Meditech
- KJ Mini Implant System — Kj Meditech
- KJ Mini Implant System — Kj Meditech
- KJ Mini Implant System — Kj Meditech
- KJ Mini Implant System — Kj Meditech
- KJ Mini Implant System — Kj Meditech
- KJ Mini Implant System — Kj Meditech
- KJ Mini Implant System — Kj Meditech
- KJ Mini Implant System — Kj Meditech
- KJ Mini Implant System — Kj Meditech
- KJ Mini Implant System — Kj Meditech
- KJ Mini Implant System — Kj Meditech
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
- Kj Meditech
Sources (1)
- FDA UDI a78a3da5-9dff-4ef1-b451-1cefefc392f0 34 fields · synced Jul 27, 2026