FDA.reportPublic FDA data

ODONCER

Primary DI
03760177042889
Brand
ODONCER
Company
TEKNIMED
Model
1000-2000µm 2cc
Catalog number
T8210202
Published
2015-10-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LYCBone Grafting Material, Synthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760177042889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760177042889037601770428893760177042889

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pore Size220Micrometer
Weight2Gram

Regulatory Flags#

DUNS number
764746723
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701505801204DynamoSpinal Cement – MV11-59202026-02-02
03701505801211Dynamo Spinal Cement System Syringe MV 1.5cc11-59212026-02-02
03701505801228DynamoSpinal Cement System Syringe MV 4cc11-59222026-02-02
03701505801235DynamoSpinal Cement System Gun MV11-59232026-02-02
03760177044326Signature -x Cement SVP/N191-14-40002026-01-23
03760177044333Signature -x Cement LVP/N191-14-40012026-01-23
03760177044340Signature -x Cement MVMVP/N191-14-40022026-01-23
03760177040090GENTAFIX1T040140G2025-09-02
03760177040137GENTAFIX3T040340G2025-09-02
03760177043176GENTAFIX3 MVT040341G2025-09-02
03760177042698Euroscrew NGØ6 L20T720620NG2023-12-18
03760177042704Euroscrew NGØ7 L24T720724NG2023-12-18
03760177042711Euroscrew NGØ7 L30T720730NG2023-12-18
03760177042728Euroscrew NGØ8 L24T720824NG2023-12-18
03760177042735Euroscrew NGØ9 L24T720924NG2023-12-18
03760177042742Euroscrew NGØ8 L30T720830NG2023-12-18
03760177042759Euroscrew NGØ9 L30T720930NG2023-12-18
03760177042766Euroscrew NGØ10 L30T721030NG2023-12-18
03760177042773Euroscrew NGØ11 L35T721135NG2023-12-18
03760177042780Euroscrew TCP NGØ06 L20T730620NG2023-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08809324765082OSTEON ll SinusGENOSS CO., Ltd.LYC2018-07-10
08809324765105OSTEON ll SinusGENOSS CO., Ltd.LYC2018-07-10
08809324765136OSTEON ll LiftingGENOSS CO., Ltd.LYC2018-07-10
08809324765174OSTEON ll LiftingGENOSS CO., Ltd.LYC2018-07-10
08809324768014OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768021OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768038OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768045OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768052OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768069OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768076OsteonIIIGENOSS CO., Ltd.LYC2018-07-10