FDA.reportPublic FDA data

OSTEO-MESH TM-300

Primary DI
D765TM454510
Brand
OSTEO-MESH TM-300
Company
Osteogenics Biomedical Inc
Model
TM4545
Device description
Titanium Ridge Augmentation Mesh, 45mm x 45mm, Nonsterile, Contents: 1 Mesh
Published
2016-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JEYPlate, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D765TM454510PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone matrix implant, metallicA sterile non-bioabsorbable device made of metal and/or metal oxide [e.g., titanium (Ti)] 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 used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically available as porous granules.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length45Millimeter
Width45Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
123853058
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D765CS0523BK0Cytoplast™ PTFE SutureCS0523BK2019-02-22
D765RPM200ATCM0RPM™ Reinforced PTFE MeshRPM200ATCM2020-07-27
D765GC3019450X-Gut™ Chromic Gut SutureGC3019452025-09-01
D765GC3019750X-Gut™ Chromic Gut SutureGC3019752025-09-01
D765GC3019P450X-Gut™ Chromic Gut SutureGC3019P452025-09-01
D765GC3019P750X-Gut™ Chromic Gut SutureGC3019P752025-09-01
D765GC4013P450X-Gut™ Chromic Gut SutureGC4013P452025-09-01
D765GC4019450X-Gut™ Chromic Gut SutureGC4019452025-09-01
D765GC4019750X-Gut™ Chromic Gut SutureGC4019752025-09-01
D765GC4019P450X-Gut™ Chromic Gut SutureGC4019P452025-09-01
D765GC5013P450X-Gut™ Chromic Gut SutureGC5013P452025-09-01
D765GC5016P450X-Gut™ Chromic Gut SutureGC5016P452025-09-01
D765GC5019450X-Gut™ Chromic Gut SutureGC5019452025-09-01
D765GP3019450X-Gut™ Plain Gut SutureGP3019452025-09-01
D765GP3019750X-Gut™ Plain Gut SutureGP3019752025-09-01
D765GP3022450X-Gut™ Plain Gut SutureGP3022452025-09-01
D765GP3024750X-Gut™ Plain Gut SutureGP3024752025-09-01
D765GP4019450X-Gut™ Plain Gut SutureGP4019452025-09-01
D765GP4019750X-Gut™ Plain Gut SutureGP4019752025-09-01
D765GC3019451X-Gut™ Chromic Gut SutureGC3019452025-09-01

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Primary DI, Brand, Company table
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