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Bluediamond Implant

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref BDC370704C

by Megagen Implant Co. Ltd

Identity

Trade Name
BLUEDIAMOND IMPLANT FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
BLUEDIAMOND IMPLANT EUDAMED
BLUEDIAMOND Implant System FDA UDI
Model / Reference
BDC370704C EUDAMED
BDC370704 FDA UDI
Description
BLUEDIAMOND Implant System FDA UDI

Identifiers

Catalog Number
BDC370704C FDA UDI
Primary DI / UDI-DI
08809931186980 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 EUDAMED
Class 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
MRI Safety
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:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Megagen Implant Co. Ltd

Sources (2)

  • FDA UDI f3f1f7cd-6a76-4769-b53d-c62f3bff0c2c 35 fields · synced Oct 7, 2026
  • EUDAMED 288e5efe-8d92-4e08-bd71-f69c33c49d46 61 fields · synced Jul 27, 2026