FDA.reportPublic FDA data

BLUEDIAMOND IMPLANT

Primary DI
08809728995450
Brand
BLUEDIAMOND IMPLANT
Company
Megagen Implant Co. Ltd
Model
ARO5808D
Catalog number
ARO5808DC
Device description
BLUEDIAMOND IMPLANT System (C4.5) Ø5.8/ L=8.5/ 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
08809728995450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809728995450088097289954508809728995450

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
08806388216789AnyRidge Internal FixtureFALIHX6007FALIHX6007C2015-06-24
08806388216840XPEED AnyRidge Internal FixtureFALIHX6507FALIHX6507C2015-06-24
08806388216901XPEED AnyRidge Internal FixtureFALIHX7007FALIHX7007C2015-06-24
08806388216963XPEED AnyRidge Internal FixtureFALIHX7507FALIHX7507C2015-06-24
08806388217021XPEED AnyRidge Internal FixtureFALIHX8007FALIHX8007C2015-06-24
08806388217571XPEED AnyRidge Internal FixtureFANIHX4507FANIHX4507C2015-06-23
08806388217649XPEED AnyRidge Internal FixtureFANIHX5007FANIHX5007C2015-06-23
08806388217854XPEED AnyRidge Internal FixtureFANIHX5507FANIHX5507C2015-06-23
08806388220588AnyOne Internal FixtureIF3507IF3507C2015-06-26
08806388220595AnyOne Internal FixtureIF3507IF35072015-06-26
08806388220601AnyOne Internal FixtureIF3508IF3508C2015-06-26
08806388220618AnyOne Internal FixtureIF3508IF35082015-06-26
08806388220625AnyOne Internal FixtureIF3510IF3510C2015-06-26
08806388220632AnyOne Internal FixtureIF3510IF35102015-06-26
08806388220649AnyOne Internal FixtureIF3511IF3511C2015-06-26
08806388220656AnyOne Internal FixtureIF3511IF35112015-06-26
08806388220663AnyOne Internal FixtureIF3513IF3513C2015-06-26
08806388220670AnyOne Internal FixtureIF3513IF35132015-06-26
08806388220687AnyOne Internal FixtureIF3515IF3515C2015-06-26
08806388220694AnyOne Internal FixtureIF3515IF35152015-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260516873062SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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