FDA.reportPublic FDA data

BCP EAGLE EYE

Primary DI
08806388226252
Brand
BCP EAGLE EYE
Company
Megagen Implant Co. Ltd
Model
MGSB0820
Catalog number
MGSB0820
Device description
Bone Plus BCP Eagle Eye [Ø0.6~1mm]/ 2g
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
08806388226252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388226252088063882262528806388226252

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
08806388243402Multi-unit Angled AbutmentMUAAOH1725TMUAAOH1725TC2021-11-18
08806388243419Multi-unit Angled AbutmentMUAAOH1735TMUAAOH1735TC2021-11-18
08806388243426Multi-unit Angled AbutmentMUAAOH3035TMUAAOH3035TC2021-11-18
08806388243433Multi-unit Angled AbutmentMUAAOH3045TMUAAOH3045TC2021-11-18
08806388243440Multi-unit Angled AbutmentMUAAON1725TMUAAON1725TC2021-11-18
08806388243457Multi-unit Angled AbutmentMUAAON1735TMUAAON1735TC2021-11-18
08806388243464Multi-unit Angled AbutmentMUAAON3035TMUAAON3035TC2021-11-18
08806388243471Multi-unit Angled AbutmentMUAAON3045TMUAAON3045TC2021-11-18
08806388243488Multi-unit Angled AbutmentMUAARH1725LMUAARH1725LC2021-11-18
08806388243495Multi-unit Angled AbutmentMUAARH1735LMUAARH1735LC2021-11-18
08806388243501Multi-unit Angled AbutmentMUAARH3035LMUAARH3035LC2021-11-18
08806388243518Multi-unit Angled AbutmentMUAARH3045LMUAARH3045LC2021-11-18
08806388243525Multi-unit Angled AbutmentMUAARN1725LMUAARN1725LC2021-11-18
08806388243532Multi-unit Angled AbutmentMUAARN1735LMUAARN1735LC2021-11-18
08806388243549Multi-unit Angled AbutmentMUAARN3035LMUAARN3035LC2021-11-18
08806388243556Multi-unit Angled AbutmentMUAARN3045LMUAARN3045LC2021-11-18
08806388247325Multi-unit Angled AbutmentMUAAON1745TMUAAON1745TC2021-11-18
08806388250455Multi-unit Angled AbutmentMUAARH1745LMUAARH1745LC2021-11-18
08806388255986Multi-unit Angled AbutmentMUAAOH1745TMUAAOH1745TC2021-11-18
08809708759935Multi-unit Angled AbutmentMUAARN1745LMUAARN1745LC2021-11-18

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ECUR9000530001CERASORB M Orthocurasan AGLYC2026-06-25
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ECUR9380000057CERASORB Bioactivecurasan AGLYC2026-06-25
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