FDA.reportPublic FDA data

BioResorb® Macro Pore

Primary DI
04260310344126
Brand
BioResorb® Macro Pore
Company
Biovision GmbH Entwicklung, Herstellung und Vertrieb von Biomaterialien
Model
KE 19010510
Catalog number
KE 19010510
Device description
1000-2000 µm; 5 x 1.0 ml
Published
2015-09-25
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
K050260000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050260000BIORESORB MACRO POREOraltronics Dental Implant Technology GmbH2005-07-15LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260310344126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260310344126042603103441264260310344126

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
332192830
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260310344003BioResorb® Macro PoreKE 19002105KE 190021052015-09-25
04260310344010BioResorb® Macro PoreKE 19002505KE 190025052015-09-25
04260310344027BioResorb® Macro PoreKE 19005105KE 190051052015-09-25
04260310344034BioResorb® Macro PoreKE 19005110KE 190051102015-09-25
04260310344041BioResorb® Macro PoreKE 19005120KE 190051202015-09-25
04260310344058BioResorb® Macro PoreKE 19005505KE 190055052015-09-25
04260310344065BioResorb® Macro PoreKE 19005510KE 190055102015-09-25
04260310344072BioResorb® Macro PoreKE 19005520KE 190055202015-09-25
04260310344089BioResorb® Macro PoreKE 19010105KE 190101052015-09-25
04260310344096BioResorb® Macro PoreKE 19010110KE 190101102015-09-25
04260310344102BioResorb® Macro PoreKE 19010120KE 190101202015-09-25
04260310344119BioResorb® Macro PoreKE 19010505KE 190105052015-09-25
04260310344133BioResorb® Macro PoreKE 19010520KE 190105202015-09-25
04260310344140BioResorb® Macro PoreKE 19014110KE 190141102015-09-25
04260310344157BioResorb® Macro PoreKE 19014120KE 190141202015-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640164360041Gibson Healthcare AlloplastDegradable Solutions AGLYC2024-03-05
07640164360065Gibson Healthcare AlloplastDegradable Solutions AGLYC2024-03-05
08720165038077OsOpiaRevisiOs B.V.LYC2021-06-30
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08809324764948OSTEONGENOSS CO., Ltd.LYC2018-07-10
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08809324764979OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764986OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764993OSTEON SinusGENOSS CO., Ltd.LYC2018-07-10
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08809324765013OSTEON LiftingGENOSS CO., Ltd.LYC2018-07-10
08809324765020OSTEON LiftingGENOSS CO., Ltd.LYC2018-07-10
08809324765082OSTEON ll SinusGENOSS CO., Ltd.LYC2018-07-10
08809324765105OSTEON ll SinusGENOSS CO., Ltd.LYC2018-07-10
08809324765136OSTEON ll LiftingGENOSS CO., Ltd.LYC2018-07-10
08809324765174OSTEON ll LiftingGENOSS CO., Ltd.LYC2018-07-10
08809324768014OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768021OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768038OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768045OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768052OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768069OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768076OsteonIIIGENOSS CO., Ltd.LYC2018-07-10