FDA.reportPublic FDA data

Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules

Primary DI
00852108006282
Brand
Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules
Company
CYTOPHIL, INC.
Model
04-030-02-MIL
Catalog number
04-030-02-MIL
Device description
Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Published
2019-10-30
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
00852108006282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852108006282008521080062828521080062820852108006282

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
Total Volume3Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
024222105
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852108006510Regento Regenerative Scaffold02-100-03-VTX202937-10 2019-10-30
00852108006251Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-030-01-MIL04-030-01-MIL2019-10-30
00852108006329Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-030-01-PIB04-030-01-PIB2019-10-30
00852108006312Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-010-01-PIB04-010-01-PIB2019-10-30
00852108006305Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-005-01-PIB04-005-01-PIB2019-10-30
00852108006404Callisto Granules Beta-TCP Synthetic Bone Graft02-050-03-VEXVX-233052019-10-30
00856509002584Trab-X SB Synthetic Bone Matrix02-050-02-VTX102937-05 2019-10-30
00852108006367Callisto Granules Beta-TCP Synthetic Bone Graft02-050-02-VEXVX-120052019-10-30
00852108006381Callisto Granules Beta-TCP Synthetic Bone Graft02-200-02-VEXVX-12020 2019-10-30
00852108006411Callisto Granules Beta-TCP Synthetic Bone Graft02-100-03-VEXVX-233102019-10-30
00856509002621Trab-X SB Synthetic Bone Matrix02-050-03-VTX202937-052019-10-30
00856509002638Trab-X SB Synthetic Bone Matrix02-100-03-VTX202937-102019-10-30
00856509002690RegenOsteo Orthopedic Beta-TCP02-050-02-RGO02-050-02-RGO2019-10-30
00856509002706RegenOsteo Orthopedic Beta-TCP02-100-02-RGO02-100-02-RGO2019-10-30
00856509002942Zavation ZV Graft Beta-TCP Synthetic Bone Graft02-030-02-ZVG02-030-02-ZVG2019-10-30
00856509002959Zavation ZV Graft Beta-TCP Synthetic Bone Graft02-030-03-ZVG02-030-03-ZVG2019-10-30
00852108006244Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-010-01-MIL04-010-01-MIL2019-10-30
00852108006275Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-010-02-MIL04-010-02-MIL2019-10-30
00852108006138Implant Logistics Synthetic Biphasic Dental Bone Graft Granules03-005-02-MIL03-005-02-MIL2019-10-30
00852108006107Implant Logistics Synthetic Biphasic Dental Bone Graft Granules03-005-01-MIL03-005-01-MIL2019-10-30

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
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08809324765020OSTEON LiftingGENOSS CO., Ltd.LYC2018-07-10
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08809324765105OSTEON ll SinusGENOSS CO., Ltd.LYC2018-07-10
08809324765136OSTEON ll LiftingGENOSS CO., Ltd.LYC2018-07-10
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