FDA.reportPublic FDA data

OsteoGen Pre-Filled Syringe - 0.3g / 0.6cc

Primary DI
00855286006082
Brand
OsteoGen Pre-Filled Syringe - 0.3g / 0.6cc
Company
Impladent, Ltd.
Model
OG-SYR
Device description
OsteoGen Bioactive Resorbable Calcium Apatite Crystals
Published
2015-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00855286006099PackageGS16In Commercial Distribution
00855286006082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855286006099008552860060998552860060990855286006099
00855286006082008552860060828552860060820855286006082

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
199838400
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855286006136TriStar Screws - 3mm (Pack of 5)TRI-032015-10-27
00855286006143TriStar Screws - 4mm (Pack of 5)TRI-042015-10-27
00855286006150TriStar Screws - 5mm (Pack of 5)TRI-052015-10-27
00855286006167TriStar Screws - 6mm (Pack of 5)TRI-062015-10-27
00855286006174TriStar Screws - 8mm (Pack of 5)TRI-082015-10-27
00855286006181TriStar Screws - 10mm (Pack of 5)TRI-102015-10-27
00855286006198TriStar Screws - 12mm (Pack of 5)TRI-122015-10-27
00855286006204TriStar Screws - 14mm (Pack of 5)TRI-142015-10-27
00855286006211TriStar Screws - 15mm (Pack of 5)TRI-152015-10-27
00855286006228TriStar Screws - 18mm (Pack of 5)TRI-182015-10-27
00855286006235TriStar Screws - 21mm (Pack of 5)TRI-212015-10-27
00855286006242TriStar Screws - 24mm (Pack of 5)TRI-242015-10-27
00855286006273OsteoGen Strip - SmallOSS122032023-08-22
00855286006358OsteoGen BlockOBB1015172023-08-22
00855286006426OsteoGen Plugs - Extra LargeOPXL15202023-08-22
00855286006112OsteoGen StripOSL204032023-08-22
00855286006129OsteoGen StripOSL204032023-08-22
00855286006266OsteoGen Strip - SmallOSS122032023-08-22
00855286006341OsteoGen BlockOBB1015172023-08-22
00855286006433OsteoGen Plugs - Extra LargeOPXL15202023-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813954028798Dyna-Bone PlugCOLLAGEN MATRIX, INC.LYC2026-07-02
00813954028804Dyna-Bone PlugCOLLAGEN MATRIX, INC.LYC2026-07-02
03700501800440MBCP+®BIOMATLANTELYC2026-06-29
03700501800457MBCP+®BIOMATLANTELYC2026-06-29
03700501800464MBCP+®BIOMATLANTELYC2026-06-29
03700501800471MBCP+®BIOMATLANTELYC2026-06-29
03700501800488MBCP+®BIOMATLANTELYC2026-06-29
03700501800495MBCP+®BIOMATLANTELYC2026-06-29
03700501800693MBCP+®BIOMATLANTELYC2026-06-29
03700501800709MBCP+®BIOMATLANTELYC2026-06-29
03700501800716MBCP+®BIOMATLANTELYC2026-06-29
00813954028767Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954028774Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954028781Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954026787SynOss PlugCOLLAGEN MATRIX, INC.LYC2025-09-05
00813954026794SynOss PlugCOLLAGEN MATRIX, INC.LYC2025-09-05
00813909010335Dental Porous Morsels 2x1.5gNOVABONE PRODUCTS, LLCLYC2025-07-17
00813909010328Dental Porous Morsels 2x0.5gNOVABONE PRODUCTS, LLCLYC2025-07-17
00813954027128PLENA PLUGCOLLAGEN MATRIX, INC.LYC2025-07-16
00813954027135PLENA PLUGCOLLAGEN MATRIX, INC.LYC2025-07-16
00813954027050TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
00813954027067TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
00813954027074TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
00813954027081TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
00813909013367Dental Putty Cartridge 2 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013374Dental Putty Cartridge 6 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013473PerioGlas - 2 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013480PerioGlas 6 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013503Dental Putty - 6 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013510Dental Putty Cartridge 4 x 0.25ccNOVABONE PRODUCTS, LLCLYC2025-04-25