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MiNi Internal Internal Fixture
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref MIIF3313CRef MIIF3610CRef MIIF3608CRef MIIF3615CRef MIIF3310C
Identity
- Trade Name
- MiNi Internal Internal Fixture FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- MiNi Internal Fixture EUDAMEDMiNi Internal Ø3/ L=10 FDA UDIMiNi Internal Ø3.25/ L=13 FDA UDIMiNi Internal Ø3.25/ L=10 FDA UDI
- Model / Reference
- MIIF3313C EUDAMEDMIIF3610C EUDAMEDMIIF3608C EUDAMEDMIIF3615C EUDAMEDMIIF3310C EUDAMEDMIIF3010 FDA UDIMIIF3313 FDA UDIMIIF3310 FDA UDI
- Description
- MiNi Internal Ø3/ L=10 FDA UDIMiNi Internal Ø3.25/ L=13 FDA UDIMiNi Internal Ø3.25/ L=10 FDA UDI
Identifiers
- Catalog Number
- MIIF3010C FDA UDIMIIF3313C FDA UDIMIIF3310C FDA UDI
- Primary DI / UDI-DI
- 08806388226986 EUDAMEDFDA UDI08806388226948 EUDAMEDFDA UDI08809977451974 EUDAMED08809977451967 EUDAMED08809977452001 EUDAMED08806388226849 FDA UDI
- Basic UDI-DI
- 880972899216Q5 EUDAMED
- 510(k) Number
- K150537 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Screw endosteal dental implant, two-piece
MiNi Internal Internal Fixture by Megagen Implant Co. Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Screw endosteal dental implant, two-piece.
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Cleared under the same submission
K150537 also covers:
- Abutment Screw — Megagen Implant Co. Ltd
- Abutment Screw — Megagen Implant Co. Ltd
- Angled Abutment — Megagen Implant Co. Ltd
- Angled Abutment — Megagen Implant Co. Ltd
- EZ Post — Megagen Implant Co. Ltd
- EZ Post — Megagen Implant Co. Ltd
- EZ Post — Megagen Implant Co. Ltd
- EZ Post — Megagen Implant Co. Ltd
- EZ Post — Megagen Implant Co. Ltd
- EZ Post — Megagen Implant Co. Ltd
- EZ Post — Megagen Implant Co. Ltd
- Guide Pin — Megagen Implant Co. Ltd
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- Megagen Implant Co. Ltd
Sources (8)
- FDA UDI e4abc70e-e0fa-45fc-8322-05ae73fe16c8 35 fields · synced Aug 1, 2026
- FDA UDI 9835d7c9-4988-4e2e-bf65-f018b4da7290 35 fields · synced May 29, 2026
- FDA UDI 000c7e40-7065-47c4-88eb-fe748da9e805 35 fields · synced May 30, 2026
- EUDAMED 4a21fc50-e096-4366-92c4-f29b060b06f5 61 fields · synced Jul 20, 2026
- EUDAMED 81af7132-55b6-45e8-8b89-5e124a5c9f02 61 fields · synced Jul 22, 2026
- EUDAMED 1e8f273a-876e-4e01-b5aa-f1c537bcd79b 61 fields · synced Jul 26, 2026
- EUDAMED 38a65594-fe27-43b1-86f3-25337c5212da 61 fields · synced Jul 30, 2026
- EUDAMED c062d59c-d3b0-4e44-9e1f-000f45192c83 61 fields · synced Aug 1, 2026