FDA.report

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
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
JEYPlate, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D765TM454510PrimaryHIBCC0

GMDN Terms

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

TypeValueUnit
Length45Millimeter
Width45Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
true

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