Osseolive Dental

Primary DI
ECURL05V0250
Brand
Osseolive Dental
Company
curasan AG
Model
250-1000µm
Catalog number
1 x 0.5 cc
Device description
Device Name: Curasan OSSEOLIVE® DENTALlndications for Use:OSSEOLIVE® DENTAL is indicated for applications in oral andmaxillofacial surgery and dentistry, including filling and/or reconstruction of multi-walled(artificial or degenerative) bone defects, e.g.:- Defects after the extirpation of bone cysts- Augmentation of an atrophied alveolar ridge- Sinus lift or sinus floor elevation (subantral augmentation)- Filling of alveolar defects after tooth extraction for preservation of the alveolar ridge- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled bone pockets as well as the bi- and trifurcation defects- Defects after operative removal of retained teeth or corrective osteotomies
Published
2017-02-11
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

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
K111105000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111105000CURASAN OSSEOLIVE DENTALCurasan AG2012-12-20LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ECURL05V0250PrimaryHIBCC0

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.

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
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

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Primary DI, Brand, Company table
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