FDA.reportPublic FDA data

SteinerBio

Primary DI
00860010170267
Brand
SteinerBio
Company
STEINER BIOTECHNOLOGY LLC.
Model
SteinerBio OsseoConduct Micron
Published
2023-04-21
Public version status
New
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
00860010170267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010170267008600101702678600101702670860010170267

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
069907701
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010170106SteinerBioSteinerBio Socket Graft 0.5 cc2023-04-21
00860010170113SteinerBioSteinerBio Socket Graft 1.0 cc2023-04-21
00860010170120SteinerBioSteinerBio Socket Graft Plus 0.5 cc2023-04-21
00860010170137SteinerBioSteinerBio Socket Graft Plus 1.0 cc2023-04-21
00860010170144SteinerBioSteinerBio Socket Graft Injectable 1.0 cc2023-04-21
00860010170151SteinerBioSteinerBio Immediate Graft2023-04-21
00860010170168SteinerBioSteinerBio BioDensification2023-04-21
00860010170175SteinerBioSteinerBio Ridge Graft Kit2023-04-21
00860010170182SteinerBioSteinerBio Sinus Graft2023-04-21
00860010170199SteinerBioSteinerBio Oral Bond2023-04-21
00860010170205SteinerBioSteinerBio OsseoConduct Perio Granules 250-500 mic2023-04-21
00860010170212SteinerBioSteinerBio OsseoConduct Perio Granules 250-500 mic2023-04-21
00860010170229SteinerBioSteinerBio OsseoConduct Standard Granules 500-10002023-04-21
00860010170236steinerBioSteinerBio OsseoConduct Standard Granules 500-10002023-04-21
00860010170243SteinerBioSteinerBio OsseoConduct Macro Granules 1000-2000 m2023-04-21
00860010170250SteinerBioSteinerBio OsseoConduct Macro Granules 1000-2000 m2023-04-21

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
07290014838116Bond ApatiteAUGMA BIOMATERIALS LTDLYC2026-02-04
07290014838123Bond ApatiteAUGMA BIOMATERIALS LTDLYC2026-02-04
072900148381783D Bond+AUGMA BIOMATERIALS LTDLYC2026-02-04
072900148381853D Bond+AUGMA BIOMATERIALS LTDLYC2026-02-04
072900148381923D Bond+AUGMA BIOMATERIALS LTDLYC2026-02-04
072900148382083D BondAUGMA BIOMATERIALS LTDLYC2026-02-04
072900148382153D BondAUGMA BIOMATERIALS LTDLYC2026-02-04
07290014838130Bond ApatiteAUGMA BIOMATERIALS LTDLYC2026-01-15
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