FDA.reportPublic FDA data

InRoad® Dental Synthetic Bone Graft

Primary DI
10810051880066
Brand
InRoad® Dental Synthetic Bone Graft
Company
Osteogene Tech Corp
Model
HA90D Small (0.3 – 1.0 mm) 3.0 cc
Catalog number
HA90D30S
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).
Published
2022-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYCBone Grafting Material, Synthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202675000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202675000InRoad® Dental Synthetic Bone GraftOsteogene Tech Corp2022-03-04LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810051880066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081005188006610810051880066

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
201-367-9321info@osteogene.com

Regulatory Flags#

DUNS number
044161695
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810051880073InRoad® Dental Synthetic Bone GraftHA90D Large (0.8 – 1.8 mm) 2.0 ccHA90D20L2023-08-23
10810051880080InRoad® Dental Synthetic Bone GraftHA90D Small (0.3 – 1.0 mm) 2.0 ccHA90D20S2023-08-23
10810051880011InRoad® Dental Synthetic Bone GraftHA90D Large (0.8 – 1.8 mm) 0.5 ccHA90D05L2022-05-25
10810051880028InRoad® Dental Synthetic Bone GraftHA90D Large (0.8 – 1.8 mm) 1.0 ccHA90D10L2022-05-25
10810051880035InRoad® Dental Synthetic Bone GraftHA90D Large (0.8 – 1.8 mm) 3.0 ccHA90D30L2022-05-25
10810051880042InRoad® Dental Synthetic Bone GraftHA90D Small (0.3 – 1.0 mm) 0.5 ccHA90D05S2022-05-25
10810051880059InRoad® Dental Synthetic Bone GraftHA90D Small (0.3 – 1.0 mm) 1.0 ccHA90D10S2022-05-25

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