FDA.reportPublic FDA data

Cerasorb M Dental

Primary DI
ECURS05M0150
Brand
Cerasorb M Dental
Company
curasan AG
Model
150-500µm
Catalog number
5 x 0.5 cc
Device description
Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recommended for:- Augmentation or reconstructive treatment of the alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection, apicoectomy and cystectomy- Filling of extraction sockets to enhance preservation of the alveolar ridge- Elevation of the maxillary sinus floor- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
Published
2017-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ECURS05M0150PrimaryHIBCC0
ECURS05M01505Unit of UseHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.5Centiliter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
324331826
Device count
5
Lot or batch
true
Manufacturing date on label
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
04260476431234IngeniOS HA0.25-1mm 1x2cc2019-10-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640164360041Gibson Healthcare AlloplastDegradable Solutions AGLYC2024-03-05
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08720165038077OsOpiaRevisiOs B.V.LYC2021-06-30
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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
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08809324768069OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
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