FDA.reportPublic FDA data

BCP EAGLE EYE

Primary DI
08806388226238
Brand
BCP EAGLE EYE
Company
Megagen Implant Co. Ltd
Model
MGSB0805
Catalog number
MGSB0805
Device description
Bone Plus BCP Eagle Eye [Ø0.6~1mm]/ 0.5g
Published
2015-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LYCBone Grafting Material, Synthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122240000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122240000BONE PLUS BCP EAGLE EYEMegagen Implant Co., Ltd.2012-08-21LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806388226238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388226238088063882262388806388226238

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone matrix implant, syntheticA sterile bioabsorbable device made of synthetic material implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is typically made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), sometimes bioactive glasses or bioabsorbable polymers, and used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

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
08806388277926Multi-unit Abutment PackageMUAARONN1725MUAARONN1725P2021-11-18
08806388220311Angled AbutmentIAA3515IAA3515T2021-07-01
08806388220328Angled AbutmentIAA3525IAA3525T2021-07-01
08806388246564AnyOne Onestage FixtureOSF3507OSF3507H2021-07-01
08806388246571AnyOne Onestage FixtureOSF3508OSF3508H2021-07-01
08806388246588AnyOne Onestage FixtureOSF3510OSF3510H2021-07-01
08806388246922AnyOne Onestage FixtureOSF3507LOSF3507LH2021-07-01
08806388246939AnyOne Onestage FixtureOSF3508LOSF3508LH2021-07-01
08806388246946AnyOne Onestage FixtureOSF3510LOSF3510LH2021-07-01
08806388243662Multi-unit Abutment PackageMUAAOH1725MUAAOH1725P2021-11-18
08806388243679Multi-unit Abutment PackageMUAAOH1735MUAAOH1735P2021-11-18
08806388243686Multi-unit Abutment PackageMUAAOH3035MUAAOH3035P2021-11-18
08806388243693Multi-unit Abutment PackageMUAAOH3045MUAAOH3045P2021-11-18
08806388243709Multi-unit Abutment PackageMUAAON1725MUAAON1725P2021-11-18
08806388243747Multi-unit Abutment PackageMUAAON0015MUAAON0015P2021-11-18
08806388243754Multi-unit Abutment PackageMUAAON0025MUAAON0025P2021-11-18
08806388243761Multi-unit Abutment PackageMUAAON0035MUAAON0035P2021-11-18
08806388243778Multi-unit Abutment PackageMUAAON0045MUAAON0045P2021-11-18
08806388243785Multi-unit Abutment PackageMUAARH1725MUAARH1725P2021-11-18
08806388243792Multi-unit Abutment PackageMUAARH1735MUAARH1735P2021-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ECUR9000301001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000305001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000310001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000405001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000410001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000430001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000510001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000530001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000630001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9380000057CERASORB Bioactivecurasan AGLYC2026-06-25
ECUR9380000058CERASORB Bioactivecurasan AGLYC2026-06-25
ECURH20V1000Osbone Dentalcurasan AGLYC2026-06-25
07640164360041Gibson Healthcare AlloplastDegradable Solutions AGLYC2024-03-05
07640164360065Gibson Healthcare AlloplastDegradable Solutions AGLYC2024-03-05
08720165038077OsOpiaRevisiOs B.V.LYC2021-06-30
08809324764870OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764887OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764894OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764900OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764917OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764924OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764931OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764948OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764955OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764962OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764979OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764986OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764993OSTEON SinusGENOSS CO., Ltd.LYC2018-07-10
08809324765006OSTEON SinusGENOSS CO., Ltd.LYC2018-07-10
08809324765013OSTEON LiftingGENOSS CO., Ltd.LYC2018-07-10