Osseolive Dental

Primary DI
ECURL05M1000
Brand
Osseolive Dental
Company
curasan AG
Model
1000-2000µm
Catalog number
5 x 0.5 cc
Device description
Device Name: Curasan OSSEOLIVE® DENTAL lndications for Use: OSSEOLIVE® DENTAL is indicated for applications in oral and maxillofacial 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
2017-10-24
Public version status
Update
Distribution status
Not 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
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
ECURL05M1000PrimaryHIBCC0
ECURL05M10005Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone void filling material, syntheticA 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
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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00813954027128PLENA PLUGCOLLAGEN MATRIX, INC.LYC2025-07-16
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