FDA.reportPublic FDA data

BCP EAGLE EYE

Primary DI
08806388226221
Brand
BCP EAGLE EYE
Company
Megagen Implant Co. Ltd
Model
MGSB0802
Catalog number
MGSB0802
Device description
Bone Plus BCP Eagle Eye [Ø0.6~1mm]/ 0.25g
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
08806388226221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388226221088063882262218806388226221

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
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
08806388243808Multi-unit Abutment PackageMUAARH3035MUAARH3035P2021-11-18
08806388243815Multi-unit Abutment PackageMUAARH3045MUAARH3045P2021-11-18
08806388243822Multi-unit Abutment PackageMUAARN0015MUAARN0015P2021-11-18
08806388243839Multi-unit Abutment PackageMUAARN0025MUAARN0025P2021-11-18
08806388243846Multi-unit Abutment PackageMUAARN0035MUAARN0035P2021-11-18
08806388243853Multi-unit Abutment PackageMUAARN0045MUAARN0045P2021-11-18
08806388243860Multi-unit Abutment PackageMUAARN1725MUAARN1725P2021-11-18
08806388243877Multi-unit Abutment PackageMUAARN1735MUAARN1735P2021-11-18
08806388243884Multi-unit Abutment PackageMUAARN3035MUAARN3035P2021-11-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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