FDA.reportPublic FDA data

IngeniOS HA

Primary DI
04260476431234
Brand
IngeniOS HA
Company
curasan AG
Model
0.25-1mm
Catalog number
1x2cc
Device description
Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistry, implantology, periodontology• Defects after removal of bone cysts• Augmentation of the atrophied alveolar ridge• Sinus floor elevation (subantral augmentation)• Filling of alveolar defects following tooth extraction for alveolar ridge preservation• Filling of extraction defects to create an implant bed• Filling of two or multi-walled infrabony pockets, and bi and trifurcation defects• Support function for a membrane in guided tissue regeneration (GTR)• Defects after surgical removal of retained teeth or corrective osteotomies• Other multi-walled bone defects of the alveolar ridge
Published
2019-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K102872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102872000OSBONE DENTALCurasan AG2011-01-12LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260476431234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260476431234042604764312344260476431234

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

Contacts#

Phone, Email table
PhoneEmail
+496027409000info@curasan.de

Regulatory Flags#

DUNS number
324331826
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ECUR449050Matriform SI-Strip50x25x4 mm1 x 5 cc2020-02-20
ECUR449100Matriform SI-Strip100x25x4mm1 x 10 cc2020-02-20
04260476431005IngeniOS ß-TCP Bioactiv Synthetic Bone Particles0.25-1mm 1x0.25cc2019-10-30
04260476431012IngeniOS ß-TCP Bioactiv Synthetic Bone Particles0.25-1mm 1x0.5cc2019-10-30
04260476431029IngeniOS ß-TCP Bioactiv Synthetic Bone Particles0.25-1mm 1x1cc2019-10-30
04260476431036IngeniOS ß-TCP Bioactiv Synthetic Bone Particles0.25-1mm 1x2cc2019-10-30
04260476431104IngeniOS ß-TCP Bioactiv Synthetic Bone Particles1-2mm 1x0.5cc2019-10-30
04260476431111IngeniOS ß-TCP Bioactiv Synthetic Bone Particles1-2mm 1x1cc2019-10-30
04260476431128IngeniOS ß-TCP Bioactiv Synthetic Bone Particles1-2mm 1x2cc2019-10-30
04260476431203IngeniOS HA0.25-1mm 1x0.25cc2019-10-30
04260476431210IngeniOS HA0.25-1mm 1x0.5cc2019-10-30
04260476431227IngeniOS HA0.25-1mm 1x1cc2019-10-30
04260476431302IngeniOS HA1-2mm 1x0.5cc2019-10-30
04260476431319IngeniOS HA1-2mm 1x1cc2019-10-30
04260476431326IngeniOS HA1-2mm 1x2cc2019-10-30
42604764310052IngeniOS ß-TCP Bioactiv Synthetic Bone Particles0.25-1mm 1x0.25cc2017-10-24
42604764310120IngeniOS ß-TCP Bioactiv Synthetic Bone Particles0.25-1mm 1x0.5cc2017-10-24
42604764310298IngeniOS ß-TCP Bioactiv Synthetic Bone Particles0.25-1mm 1x1cc2017-10-24
42604764310366IngeniOS ß-TCP Bioactiv Synthetic Bone Particles0.25-1mm 1x2cc2017-10-24
42604764311042IngeniOS ß-TCP Bioactiv Synthetic Bone Particles1-2mm 1x0.5cc2017-10-24

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
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
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