FDA.reportPublic FDA data

IngeniOS ß-TCP Bioactiv Synthetic Bone Particles

Primary DI
04260476431111
Brand
IngeniOS ß-TCP Bioactiv Synthetic Bone Particles
Company
curasan AG
Model
1-2mm
Catalog number
1x1cc
Device description
Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use: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
Published
2019-10-30
Public version status
New
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
LPKBone Grafting Material, For Dental Bone Repair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPKBone Grafting Material, For Dental Bone Repair

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
04260476431111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260476431111042604764311114260476431111

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
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
42604764311042IngeniOS ß-TCP Bioactiv Synthetic Bone Particles1-2mm 1x0.5cc2017-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260476431005IngeniOS ß-TCP Bioactiv Synthetic Bone Particlescurasan AGLPK2019-10-30
04260476431012IngeniOS ß-TCP Bioactiv Synthetic Bone Particlescurasan AGLPK2019-10-30
04260476431029IngeniOS ß-TCP Bioactiv Synthetic Bone Particlescurasan AGLPK2019-10-30
04260476431036IngeniOS ß-TCP Bioactiv Synthetic Bone Particlescurasan AGLPK2019-10-30
04260476431104IngeniOS ß-TCP Bioactiv Synthetic Bone Particlescurasan AGLPK2019-10-30
04260476431128IngeniOS ß-TCP Bioactiv Synthetic Bone Particlescurasan AGLPK2019-10-30
42604764310052IngeniOS ß-TCP Bioactiv Synthetic Bone Particlescurasan AGLPK2017-10-24
42604764310120IngeniOS ß-TCP Bioactiv Synthetic Bone Particlescurasan AGLPK2017-10-24
42604764310298IngeniOS ß-TCP Bioactiv Synthetic Bone Particlescurasan AGLPK2017-10-24
42604764310366IngeniOS ß-TCP Bioactiv Synthetic Bone Particlescurasan AGLPK2017-10-24
42604764311042IngeniOS ß-TCP Bioactiv Synthetic Bone Particlescurasan AGLPK2017-10-24
42604764311110IngeniOS ß-TCP Bioactiv Synthetic Bone Particlescurasan AGLPK2017-10-24
42604764311288IngeniOS ß-TCP Bioactiv Synthetic Bone Particlescurasan AGLPK2017-10-24
H98071000098S0ChronOSSYNTHES (U.S.A.) LPLPK2015-09-14
H98071000398S0ChronOSSYNTHES (U.S.A.) LPLPK2015-09-14