FDA.reportPublic FDA data

Implant Logistics Synthetic Biphasic Dental Bone Graft Granules

Primary DI
00852108006121
Brand
Implant Logistics Synthetic Biphasic Dental Bone Graft Granules
Company
CYTOPHIL, INC.
Model
03-030-01-MIL
Catalog number
03-030-01-MIL
Device description
Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended 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
OTC
false
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
00852108006121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852108006121008521080061218521080061210852108006121

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
024222105
Device count
1
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
00852108006107Implant Logistics Synthetic Biphasic Dental Bone Graft Granules03-005-01-MIL03-005-01-MIL2019-10-30
00852108006114Implant Logistics Synthetic Biphasic Dental Bone Graft Granules03-010-01-MIL03-010-01-MIL2019-10-30
00852108006138Implant Logistics Synthetic Biphasic Dental Bone Graft Granules03-005-02-MIL03-005-02-MIL2019-10-30
00852108006152Implant Logistics Synthetic Biphasic Dental Bone Graft Granules03-030-02-MIL03-030-02-MIL2019-10-30
00852108006169Osteo-i Synthetic Biphasic Dental Bone Graft Granules03-005-01-SASOST4012019-10-30
00852108006176Osteo-i Synthetic Biphasic Dental Bone Graft Granules03-010-01-SASOST4022019-10-30
00852108006183Osteo-i Synthetic Biphasic Dental Bone Graft Granules03-030-01-SASOST4132019-10-30
00852108006190Osteo-i Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-005-01-SASOST4042019-10-30
00852108006206Osteo-i Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-010-01-SASOST4052019-10-30
00852108006237Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-005-01-MIL04-005-01-MIL2019-10-30
00852108006244Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-010-01-MIL04-010-01-MIL2019-10-30
00852108006251Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-030-01-MIL04-030-01-MIL2019-10-30
00852108006268Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-005-02-MIL04-005-02-MIL2019-10-30
00852108006275Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-010-02-MIL04-010-02-MIL2019-10-30
00852108006282Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-030-02-MIL04-030-02-MIL2019-10-30
00852108006299Bio | TCP Beta-Tricalcium Phosphate Porous Granulate04-010-01-BSBBTCP2512019-10-30
00852108006305Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-005-01-PIB04-005-01-PIB2019-10-30
00852108006312Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-010-01-PIB04-010-01-PIB2019-10-30
00852108006329Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-030-01-PIB04-030-01-PIB2019-10-30
00852108006367Callisto Granules Beta-TCP Synthetic Bone Graft02-050-02-VEXVX-120052019-10-30

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