FDA.reportPublic FDA data

BLUEDIAMOND IMPLANT

Primary DI
08809977452681
Brand
BLUEDIAMOND IMPLANT
Company
Megagen Implant Co. Ltd
Model
BDC410904C
Device description
(c3.5) Ø4.1x9.0 (4)
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241972000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241972000BLUEDIAMOND IMPLANTMegagen Implant Co., Ltd.2024-12-27DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809977452681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809977452681088099774526818809977452681

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
687388178
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
08809977452704BLUEDIAMOND IMPLANTBDC410904DC2026-09-04
08809977452728BLUEDIAMOND IMPLANTBDC410906C2026-09-04
08809977452742BLUEDIAMOND IMPLANTBDC410906DC2026-09-04
08809977452766BLUEDIAMOND IMPLANTBDC440506C2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800077000031ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000055ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000079ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000093ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000116ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000130ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000154ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000178ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000192ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000215ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000239ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000253ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000277ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000291ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000321ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000345ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000369ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000383ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000406ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000437ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000451ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000475ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000499ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000512ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000543ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000567ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000581ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000604ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000628ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077001038ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30