FDA.reportPublic FDA data

BLUEDIAMOND IMPLANT

Primary DI
08809728995405
Brand
BLUEDIAMOND IMPLANT
Company
Megagen Implant Co. Ltd
Model
ARO5311D
Catalog number
ARO5311DC
Device description
BLUEDIAMOND IMPLANT System (C4.5) Ø5.3/ L=11.5/ DT
Published
2023-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211812000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211812000BLUEDIAMOND IMPLANT, Abutment ScrewMegagen Implant Co., Ltd.2023-01-06DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809728995405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809728995405088097289954058809728995405

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687388178
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806388226221BCP EAGLE EYEMGSB0802MGSB08022015-06-29
08806388226238BCP EAGLE EYEMGSB0805MGSB08052015-06-29
08806388226245BCP EAGLE EYEMGSB0810MGSB08102015-06-29
08806388226252BCP EAGLE EYEMGSB0820MGSB08202015-06-29
08806388271504Mega-Oss BovineTMIOSG025IOSG0252018-10-15
08806388271511Mega-Oss BovineTMIOSG050IOSG0502018-10-15
08806388271528Mega-Oss BovineTMIOSG100IOSG1002018-10-15
08806388271535Mega-Oss BovineTMIOSG200IOSG2002018-10-15
08806388271542Mega-Oss BovineTMIOSG500IOSG5002018-10-15
08806388271559Mega-Oss BovineTMIOLG050IOLG0502018-10-15
08806388271566Mega-Oss BovineTMIOLG100IOLG1002018-10-15
08806388271573Mega-Oss BovineTMIOLG200IOLG2002018-10-15
08809977452445BLUEDIAMOND IMPLANTBDC410506C2026-09-04
08809977452469BLUEDIAMOND IMPLANTBDC410506DC2026-09-04
08809977452568BLUEDIAMOND IMPLANTBDC410706C2026-09-04
08809977452582BLUEDIAMOND IMPLANTBDC410706DC2026-09-04
08809977452681BLUEDIAMOND IMPLANTBDC410904C2026-09-04
08809977452704BLUEDIAMOND IMPLANTBDC410904DC2026-09-04
08809977452728BLUEDIAMOND IMPLANTBDC410906C2026-09-04
08809977452742BLUEDIAMOND IMPLANTBDC410906DC2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968494068plant Implant System8dent Inc.NHA2026-10-20
088000968498338plant Implant System8dent Inc.NHA2026-10-20
088000968514618plant Implant System8dent Inc.NHA2026-10-20
088000968514788plant Implant System8dent Inc.NHA2026-10-20
088000968514858plant Implant System8dent Inc.NHA2026-10-20
088000968515778plant Implant System8dent Inc.NHA2026-10-20
088000968611568plant Implant System8dent Inc.NHA2026-10-20
088000968621608plant Implant System8dent Inc.NHA2026-10-20
088000968621778plant Implant System8dent Inc.NHA2026-10-20
088000968642878plant Implant System8dent Inc.NHA2026-10-20
088000968645778plant Implant System8dent Inc.NHA2026-10-20
088000968782398plant Implant System8dent Inc.NHA2026-10-20
08809984970062S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970079S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970086S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970093S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970109S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970116S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970123S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970130S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970147S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970154S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970161S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970178S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970185S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970192S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970208S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970222S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970239S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970246S-PlantIDIS CO.,LTDDZE2026-10-20