Identity
- Trade Name
- BLUEDIAMOND IMPLANT FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- BLUEDIAMOND IMPLANT EUDAMEDBLUEDIAMOND IMPLANT System (C4.5) Ø5.3/ L=7/ DT FDA UDI
- Model / Reference
- ARO5307DC EUDAMEDARO5307D FDA UDI
- Description
- BLUEDIAMOND IMPLANT System (C4.5) Ø5.3/ L=7/ DT FDA UDI
Identifiers
- Catalog Number
- ARO5307DC FDA UDI
- Primary DI / UDI-DI
- 08809728995375 EUDAMEDFDA UDI
- Basic UDI-DI
- 880972899853D EUDAMED
- 510(k) Number
- K211812 FDA UDI
- FDA Product Code
- DZE FDA UDINHA 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 UDI872.3630 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Screw endosteal dental implant, two-piece
Bluediamond Implant 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
K211812 also covers:
- Abutment Screw — Megagen Implant Co. Ltd
- Abutment Screw — Megagen Implant Co. Ltd
- BLUEDIAMOND IMPLANT — Megagen Implant Co. Ltd
- BLUEDIAMOND IMPLANT — Megagen Implant Co. Ltd
- BLUEDIAMOND IMPLANT — Megagen Implant Co. Ltd
- BLUEDIAMOND IMPLANT — Megagen Implant Co. Ltd
- BLUEDIAMOND IMPLANT — Megagen Implant Co. Ltd
- BLUEDIAMOND IMPLANT — Megagen Implant Co. Ltd
- BLUEDIAMOND IMPLANT — Megagen Implant Co. Ltd
- BLUEDIAMOND IMPLANT — Megagen Implant Co. Ltd
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 |
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Manufacturer
- Manufacturer
- Megagen Implant Co. Ltd
Sources (2)
- FDA UDI 02241b36-79eb-48ec-80a2-a0cb75841040 35 fields · synced Jul 20, 2026
- EUDAMED 4b401147-60f0-4911-8cab-9c21068f2b30 61 fields · synced Jul 20, 2026