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Osteo-Mesh Tm-300

FDA UDI

Class II (US FDA UDI)

by Osteogenics Biomedical, Inc.

Identity

Trade Name
OSTEO-MESH TM-300 FDA UDI
Generic Name
Dental bone matrix implant, metallic FDA UDI
Device Name
Titanium Ridge Augmentation Mesh, 25mm x 34mm, Nonsterile, Contents: 1 Mesh FDA UDI
Model / Reference
TM2534 FDA UDI
Description
Titanium Ridge Augmentation Mesh, 25mm x 34mm, Nonsterile, Contents: 1 Mesh FDA UDI

Identifiers

Primary DI / UDI-DI
D765TM253410 FDA UDI
FDA Product Code
JEY FDA UDI
GMDN Term
Dental bone matrix implant, metallic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4760 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Length — 34 Millimeter FDA UDI
Width — 25 Millimeter FDA UDI

Category: Dental bone matrix implant, metallic

Osteo-Mesh Tm-300 by Osteogenics Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental bone matrix implant, metallic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osteogenics Biomedical, Inc.

Sources (1)

  • FDA UDI 00f10bc8-6dda-4f1b-81a6-3f6f50497f80 34 fields · synced May 29, 2026