CERASORB Bioactive

Primary DI
ECUR9380000057
Brand
CERASORB Bioactive
Company
curasan AG
Model
0.25-1mm
Catalog number
5x0.5cc
Device description
Device Name: CERASORB Bioactive Indications: Oral and maxillofacial surgery and dentistry • Augmentation or reconstructive treatment of the alveolar ridge • Filling of infrabony periodontal defects • Filling of defects after root resection, apicoectomy, and cystectomy • Filing 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 Regenera-tion (GTR) and Guided Bone Regeneration (GBR) • Filling of perio-implant defects in conjunction with products intended for Guided Bone Regenera-tion (GBR)
Published
2026-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K103709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103709000CERACELL DENTALCurasan AG2011-03-10LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ECUR9380000057PrimaryHIBCC0
ECUR93800000575Unit 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.

Contacts#

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

Regulatory Flags#

DUNS number
324331826
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ECUR9000301001CERASORB M Ortho1000-2000µm1 x 1.0 cc2026-06-25
ECUR9000305001CERASORB M Ortho1000-2000µm1 x 5.0 cc2026-06-25
ECUR9000310001CERASORB M Ortho1000-2000µm1 x 10.0 cc2026-06-25
ECUR9000405001CERASORB M Ortho2000-3000µm1 x 5.0 cc2026-06-25
ECUR9000410001CERASORB M Ortho2000-3000µm1 x 10.0 cc2026-06-25
ECUR9000430001CERASORB M Ortho2000-3000µm3 x 10.0 cc2026-06-25
ECUR9000510001CERASORB M Ortho3000-5000µm1 x 10.0 cc2026-06-25
ECUR9000530001CERASORB M Ortho3000-5000µm3 x 10.0 cc2026-06-25
ECUR9000630001CERASORB M Ortho5000-8000µm3 x 10.0 cc2026-06-25
ECUR9380000058CERASORB Bioactive1-2mm5x1.0cc2026-06-25
ECUR9920302VerteFrame25x25x4 mm1 x 2.5 cc2026-06-25
ECUR9920305VerteFrame25x50x4 mm1 x 5.0 cc2026-06-25
ECUR9920310VerteFrame25x100x4mm1 x 10.0 cc2026-06-25
ECURCCLF25100CERACELL Ortho Foam25x100x4 mm1 x 10.0 cc2026-06-25
ECURCCLF25250CERACELL Ortho Foam65x65x6 mm1 x 25.0 cc2026-06-25
ECURCCLF2550CERACELL Ortho Foam25x50x4 mm1 x 5.0 cc2026-06-25
ECURCCLM25100CERACELL Ortho Foam25x100x4 mm1 x 10.0 cc2026-06-25
ECURCCLM2512CERACELL Ortho Foam25x12x4 mm1 x 1.2 cc2026-06-25
ECURCCLM2525CERACELL Ortho Foam25x25x4 mm1 x 2.5 cc2026-06-25
ECURCCLM2550CERACELL Ortho Foam25x50x4 mm1 x 5.0 cc2026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ECUR9000301001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000305001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000310001CERASORB M Orthocurasan AGLYC2026-06-25
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
ECUR9380000058CERASORB Bioactivecurasan AGLYC2026-06-25
ECURH20V1000Osbone Dentalcurasan AGLYC2026-06-25
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