Osbone Dental

Primary DI
ECURH20M1000
Brand
Osbone Dental
Company
curasan AG
Model
1000-2000µm
Catalog number
1 x 2.0 cc
Device description
Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.:- Defects after removal of bone cysts- Augmentation of the atrophied alveolar ridge- Sinus lift and 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 controlled tissue regeneration (CTR)- Defects after surgical removal of retained teeth or corrective osteotomies- Other multi-walled bone defects of the alveolar processes
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

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
ECURH20M1000PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume2Centiliter

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
Manufacturing date on label
true
Expiration date on label
true

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
ECUR9380000057CERASORB Bioactive0.25-1mm5x0.5cc2026-06-25
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

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