FDA.reportPublic FDA data

BLUEDIAMOND IMPLANT

Primary DI
08809728995382
Brand
BLUEDIAMOND IMPLANT
Company
Megagen Implant Co. Ltd
Model
ARO5308D
Catalog number
ARO5308DC
Device description
BLUEDIAMOND IMPLANT System (C4.5) Ø5.3/ 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
08809728995382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809728995382088097289953828809728995382

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
08806388266173ZrGEN AbutmentARZXM503825ARZXM503825.MTN2024-01-31
08806388244812ZrGEN AbutmentARZXM5015ARZXM5015.MTN2023-06-22
08806388244829ZrGEN AbutmentARZXM5525ARZXM5525.MTN2023-06-22
08806388244836ZrGEN AbutmentARZXM5016ARZXM5016.MTN2023-06-22
08806388244843ZrGEN AbutmentARZXM5526ARZXM5526.MTN2023-06-22
08806388244850ZrGEN AbutmentARZXM5015NARZXM5015N.MTN2023-06-22
08806388244867ZrGEN AbutmentARZXM5525NARZXM5525N.MTN2023-06-22
08806388244874ZrGEN AbutmentARZXM5016NARZXM5016N.MTN2023-06-22
08806388244898ZrGEN AbutmentARZXL5515ARZXL5515.MTN2023-06-22
08806388244904ZrGEN AbutmentARZXL6025ARZXL6025.MTN2023-06-22
08806388244911ZrGEN AbutmentARZXL5516ARZXL5516.MTN2023-06-22
08806388244928ZrGEN AbutmentARZXL6026ARZXL6026.MTN2023-06-22
08806388244935ZrGEN AbutmentARZXL5515NARZXL5515N.MTN2023-06-22
08806388244942ZrGEN AbutmentARZXL6025NARZXL6025N.MTN2023-06-22
08806388244959ZrGEN AbutmentARZXL5516NARZXL5516N.MTN2023-06-22
08806388244966ZrGEN AbutmentARZXL6026NARZXL6026N.MTN2023-06-22
08806388256624ZrGEN AbutmentAROZGN4015AROZGN4015T2023-06-22
08806388256631ZrGEN AbutmentAROZGN4025AROZGN4025T2023-06-22
08806388256648ZrGEN AbutmentAROZGR4515AROZGR4515T2023-06-22
08806388256655ZrGEN AbutmentAROZGR4525AROZGR4525T2023-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532281730ATLANTIS®DENTSPLY IH, INC.NHA2026-07-29
07392532281747ATLANTIS®DENTSPLY IH, INC.NHA2026-07-29
08809917132710Healing Abutment SystemOsstem Implant Co., Ltd.NHA2026-07-29
08800070230008ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-07-29
08800070201619ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
08800070218600ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
08800070218891ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
08800070223673Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223710Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223758Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223796Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070224236Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224274Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224311Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224359Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070228333ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
07899995243898FIXATION SCREW CM11.5° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243904FIXATION SCREW CM11.5° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243928PARAF. DE FIXACAO MT16° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243935PARAF. DE FIXACAO MT16° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
08806388266173ZrGEN AbutmentMegagen Implant Co. LtdNHA2024-01-31
07630031764263Straumann® BLC Implants - Indication WideningInstitut Straumann AGDZE2023-11-04
07630031764331Straumann® BLC Implants - Indication WideningInstitut Straumann AGDZE2023-11-04
08806388244812ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244829ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244836ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244843ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244850ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244867ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244874ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22