FDA.reportPublic FDA data

Cytoplast™ Non-Resorbable PTFE Barrier Membranes, Titanium-Reinforced

Primary DI
D765TI250BLL21
Brand
Cytoplast™ Non-Resorbable PTFE Barrier Membranes, Titanium-Reinforced
Company
Osteogenics Biomedical Inc
Model
Ti250BLL-2
Device description
Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 17 mm x 30 mm
Published
2022-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
D765TI250BLL21PackageHIBCC2In Commercial Distribution
D765TI250BLL20PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pliable-polymer dental regeneration membrane, non-bioabsorbableA sterile non-bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. It is a pliable synthetic polymer material that is held in place between soft tissue and bone [e.g., with ligatures, sutures, or pins (may be attached/included)] and applied during periodontal flap surgery and other guided bone regeneration (GBR) and guided tissue regeneration (GTR) surgical procedures. A plasticizer to soften the membrane may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Millimeter
Width17Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
123853058
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
D765GC3019451X-Gut™ Chromic Gut SutureGC3019452025-09-01
D765GC3019751X-Gut™ Chromic Gut SutureGC3019752025-09-01
D765GC3019P451X-Gut™ Chromic Gut SutureGC3019P452025-09-01
D765GC3019P751X-Gut™ Chromic Gut SutureGC3019P752025-09-01
D765GC4013P451X-Gut™ Chromic Gut SutureGC4013P452025-09-01
D765GC4019451X-Gut™ Chromic Gut SutureGC4019452025-09-01
D765GC4019751X-Gut™ Chromic Gut SutureGC4019752025-09-01
D765GC4019P451X-Gut™ Chromic Gut SutureGC4019P452025-09-01
D765GC5013P451X-Gut™ Chromic Gut SutureGC5013P452025-09-01
D765GC5016P451X-Gut™ Chromic Gut SutureGC5016P452025-09-01
D765GC5019451X-Gut™ Chromic Gut SutureGC5019452025-09-01
D765GP3019451X-Gut™ Plain Gut SutureGP3019452025-09-01
D765GP3019751X-Gut™ Plain Gut SutureGP3019752025-09-01
D765GP3022451X-Gut™ Plain Gut SutureGP3022452025-09-01
D765GP3024751X-Gut™ Plain Gut SutureGP3024752025-09-01
D765GP4019451X-Gut™ Plain Gut SutureGP4019452025-09-01
D765GP4019751X-Gut™ Plain Gut SutureGP4019752025-09-01
D765ZXSOCKET10ZCORE™ EXPANDZXSOCKET-12025-04-14
D765ZXSOCKET101ZCORE™ EXPANDZXSOCKET-102025-04-14
D765ZXSOCKET51ZCORE™ EXPANDZXSOCKET-52025-04-14

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Primary DI, Brand, Company table
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00813954028873PuraKOTE+COLLAGEN MATRIX, INC.LYC2026-05-26
00813954028897PuraTAPE+COLLAGEN MATRIX, INC.LYC2026-05-26
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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
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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
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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
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00813909013343Dental Putty Syringe 2.0ccNOVABONE PRODUCTS, LLCLYC2025-04-25
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