Identity
- Trade Name
- Mini Plus Implant System FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Model / Reference
- AMB3412 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800016101546 FDA UDI
- 510(k) Number
- K090049 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
Mini Plus Implant System by Cowellmedi Co., Ltd — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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
Cleared under the same submission
K090049 also covers:
- Mini Plus Implant System — Cowellmedi Co., Ltd
- Mini Plus Implant System — Cowellmedi Co., Ltd
- Mini Plus Implant System — Cowellmedi Co., Ltd
- Mini Plus Implant System — Cowellmedi Co., Ltd
- Mini Plus Implant System — Cowellmedi Co., Ltd
- Mini Plus Implant System — Cowellmedi Co., Ltd
- Mini Plus Implant System — Cowellmedi Co., Ltd
- Mini Plus Implant System — Cowellmedi Co., Ltd
- Mini Plus Implant System — Cowellmedi Co., Ltd
- Mini Plus Implant System — Cowellmedi Co., Ltd
- Mini Plus Implant System — Cowellmedi Co., Ltd
- Mini Plus Implant System — Cowellmedi Co., Ltd
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cowellmedi Co., Ltd
Sources (2)
- FDA UDI ab0a23bd-e92a-45f4-91b4-995f223f9851 33 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026