Identity
- Trade Name
- BLUEDIAMOND IMPLANT FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- BLUEDIAMOND IMPLANT EUDAMEDBLUEDIAMOND Implant System FDA UDI
- Model / Reference
- BDC370904C EUDAMEDBDC370904 FDA UDI
- Description
- BLUEDIAMOND Implant System FDA UDI
Identifiers
- Catalog Number
- BDC370904C FDA UDI
- Primary DI / UDI-DI
- 08809977452360 EUDAMEDFDA UDI
- Basic UDI-DI
- 880972899853D EUDAMED
- 510(k) Number
- K241972 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
MR Conditional FDA UDI
Bluediamond Implant by Megagen Implant Co. Ltd — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K241972 also covers:
- 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
- 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 (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 |
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Manufacturer
- Manufacturer
- Megagen Implant Co. Ltd
Sources (2)
- FDA UDI a181f9a2-fbfe-4568-8e55-ffdac074fda5 35 fields · synced Oct 7, 2026
- EUDAMED 9b84a356-b58e-4ec5-881f-78c952a5bd2f 61 fields · synced Jul 19, 2026