InRoad® Dental Synthetic Bone Graft

Basic Information

• Brand Name: InRoad® Dental Synthetic Bone Graft
• Primary DI: 10810051880035
• Version / Model: HA90D Large (0.8 – 1.8 mm) 3.0 cc
• Catalog Number: HA90D30L
• Company Name: Osteogene Tech Corp
• Labeler DUNS: 044161695
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-25
• Public Version: 1
• Public Version Date: 2022-06-02
• Public Version Status: New
• Public Device Record Key: 8265770a-b85e-4bca-b78c-5a48ffbae69b

Device Description

InRoad® Dental Synthetic Bone Graft (SBG) is a synthetic, semi-dense multi-porous bioceramic for bone regeneration. It is comprised of 90% ± 5% hydroxyapatite (HA) and 10% ± 5% Beta-Tricalcium Phosphate. The granules are provided sterile (gamma irradiated) in a capped vial packaged in a lid sealed tray. InRoad® Dental SBG granules are designed to resemble trabecular bone structure. The granule structure consists of interconnected primary open pores, secondary channel-like structure, and tertiary small holes on the surface in a biocompatible and osteoconductive biomaterial. The multi-porous structure of InRoad® Dental SBG makes it possible for the bone cells to migrate into the matrices and for new bone to grow. InRoad® Dental SBG is available in granule form in sizes of 0.3 – 1.0 mm (Small) and 0.8 – 1.8 mm (Large).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYC	Bone Grafting Material, Synthetic	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16966	Synthetic bone graft	An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810051880035	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K202675	000