FDA.reportPublic FDA data

BLUEDIAMOND IMPLANT

Primary DI
08809985666735
Brand
BLUEDIAMOND IMPLANT
Company
Megagen Implant Co. Ltd
Model
BDC480906D
Catalog number
BDC480906DC
Device description
Ø4.8x9.0 DT
Published
2025-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

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
08809985666735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809985666735088099856667358809985666735

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

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
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
08809977452766BLUEDIAMOND IMPLANTBDC440506C2026-09-04
08809977452780BLUEDIAMOND IMPLANTBDC440506DC2026-09-04
08809977452889BLUEDIAMOND IMPLANTBDC440706C2026-09-04
08809977452902BLUEDIAMOND IMPLANTBDC440706DC2026-09-04
08809977453008BLUEDIAMOND IMPLANTBDC440904C2026-09-04
08809977453022BLUEDIAMOND IMPLANTBDC440904DC2026-09-04
08809977453046BLUEDIAMOND IMPLANTBDC440906C2026-09-04
08809977453060BLUEDIAMOND IMPLANTBDC440906DC2026-09-04
08806388243402Multi-unit Angled AbutmentMUAAOH1725TMUAAOH1725TC2021-11-18
08806388243419Multi-unit Angled AbutmentMUAAOH1735TMUAAOH1735TC2021-11-18
08806388243426Multi-unit Angled AbutmentMUAAOH3035TMUAAOH3035TC2021-11-18
08806388243433Multi-unit Angled AbutmentMUAAOH3045TMUAAOH3045TC2021-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899878068181NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068198NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068211NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068228NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068235NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068242NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068259NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07392532151156Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532151163Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192425Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192449Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192456Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192463Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192470Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192487Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532186622N/ADentsply Implants Manufacturing GmbHNHA2020-11-18
07392532186639N/ADentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216343ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216350ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216367ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216374ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216381ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216398ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216404ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216411ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216428ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216435ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216442ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216459ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216466ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18