FDA.reportPublic FDA data

RegenerOss Synthetic

Primary DI
00813954022420
Brand
RegenerOss Synthetic
Company
COLLAGEN MATRIX, INC.
Model
ROSBGP05
Device description
Synthetic Mineral-Collagen Composite Bone Graft
Published
2018-04-05
Public version status
New
Distribution status
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
00813954022420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813954022420008139540224208139540224200813954022420

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
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176262442
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
00813954028767Gibson Healthcare Alloplast6247-9926247-9922026-05-26
00813954028774Gibson Healthcare Alloplast6248-0086248-0082026-05-26
00813954028781Gibson Healthcare Alloplast6248-0176248-0172026-05-26
00813954028873PuraKOTE+PGKTE+PGKTE+2026-05-26
00813954028880PuraPLUG+PGPLG+PGPLG+2026-05-26
00813954028897PuraTAPE+PGTPE+PGTPE+2026-05-26
00813954028590bioMAINTAINOUSA1EUOUSA1EU2026-03-23
00813954028606bioMAINTAINOUSA2EUOUSA2EU2026-03-23
00813954028613bioMAINTAINOUSA3EUOUSA3EU2026-03-23
00813954028484XENOFY-PXFP-050050XFP-0500502026-03-12
00813954028491XENOFY-PXFP-050100XFP-0501002026-03-12
00813954028507XENOFY-PXFP-050200XFP-0502002026-03-12
00813954028514XENOFY-PXFP-050400XFP-0504002026-03-12
00813954028521XENOFY-PXFP-051100XFP-0511002026-03-12
00813954028538XENOFY-PXFP-051200XFP-0512002026-03-12
10813954028436Tissue Specialists Resorbable Collagen PlugT5094000T50940002026-03-09
10813954028443Tissue Specialists Resorbable Collagen TapeT5091000T50910002026-03-09
00813954028453Tissue Specialists Resorbable Collagen MembraneT5096000T50960002026-03-09
00813954028460Tissue Specialists Resorbable Collagen MembraneT5093000T50930002026-03-09
00813954028477Tissue Specialists Resorbable Collagen MembraneT5098000T50980002026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813954028767Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954028774Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954028781Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954028873PuraKOTE+COLLAGEN MATRIX, INC.LYC2026-05-26
00813954028897PuraTAPE+COLLAGEN MATRIX, INC.LYC2026-05-26
10813954028542bioSTRIPCOLLAGEN MATRIX, INC.LYC2026-03-09
10813954028566bioKOTECOLLAGEN MATRIX, INC.LYC2026-03-09
14550565002269Cytrans GranulesGc America Inc.LYC2026-03-03
14550565002276Cytrans GranulesGc America Inc.LYC2026-03-03
D047014615Cytrans GranulesGc America Inc.LYC2026-03-03
D047014616Cytrans GranulesGc America Inc.LYC2026-03-03
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
00813954028392SynOssCOLLAGEN MATRIX, INC.LYC2026-01-06
00813954028408SynOssCOLLAGEN MATRIX, INC.LYC2026-01-06
00813954028415SynOssCOLLAGEN MATRIX, INC.LYC2026-01-06
00813954028422SynOssCOLLAGEN MATRIX, INC.LYC2026-01-06
00813909010328Dental Porous Morsels 2x0.5gNOVABONE PRODUCTS, LLCLYC2025-07-17
00813909013756Dental Porous Morsels 2x1.5gNOVABONE PRODUCTS, LLCLYC2025-07-17
00813954027081TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
00813909013329Dental Putty Syringe 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013336Dental Putty Syringe 1.0ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013343Dental Putty Syringe 2.0ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013558Dental Putty Cartridge 2 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25