FDA.reportPublic FDA data

BLUEDIAMOND IMPLANT

Primary DI
08809728995481
Brand
BLUEDIAMOND IMPLANT
Company
Megagen Implant Co. Ltd
Model
ARO5813D
Catalog number
ARO5813DC
Device description
BLUEDIAMOND IMPLANT System (C4.5) Ø5.8/ L=13/ 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
08809728995481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809728995481088097289954818809728995481

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
08806388205226Esthetic Healing AbutmentAEHR402AEHR4022021-11-18
08806388205233Esthetic Healing AbutmentAEHR403AEHR4032021-11-18
08806388205240Esthetic Healing AbutmentAEHR404AEHR4042021-11-18
08806388205257Esthetic Healing AbutmentAEHS302AEHS3022021-11-18
08806388205264Esthetic Healing AbutmentAEHS303AEHS3032021-11-18
08806388205271Esthetic Healing AbutmentAEHS304AEHS3042021-11-18
08806388205288Esthetic Healing AbutmentAEHW502AEHW5022021-11-18
08806388205295Esthetic Healing AbutmentAEHW503AEHW5032021-11-18
08806388205301Esthetic Healing AbutmentAEHW504AEHW5042021-11-18
08806388213023AnyOne External FixtureEF3507EF3507P2021-11-18
08806388213047AnyOne External FixtureEF3508EF3508P2021-11-18
08806388213061AnyOne External FixtureEF3510EF3510P2021-11-18
08806388213085AnyOne External FixtureEF3511EF3511P2021-11-18
08806388213108AnyOne External FixtureEF3513EF3513P2021-11-18
08806388213122AnyOne External FixtureEF3515EF3515P2021-11-18
08806388213146AnyOne External FixtureEF4007EF4007P2021-11-18
08806388213160AnyOne External FixtureEF4008EF4008P2021-11-18
08806388213184AnyOne External FixtureEF4010EF4010P2021-11-18
08806388213207AnyOne External FixtureEF4011EF4011P2021-11-18
08806388213221AnyOne External FixtureEF4013EF4013P2021-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806388205226Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205226Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205233Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205233Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205240Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205240Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205257Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205257Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205264Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205264Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205271Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205271Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205288Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205288Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205295Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205295Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205301Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205301Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388213023AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213023AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213047AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213047AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213061AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213061AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213085AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213085AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213108AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213108AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213122AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213122AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18