InRoad® Dental Synthetic Bone Graft

FDA UDI

Class II (US FDA UDI)

by Osteogene Tech Corp

Identity

Trade Name: InRoad® Dental Synthetic Bone Graft FDA UDI
Generic Name: Synthetic bone graft FDA UDI
Device Name: 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). FDA UDI
Model / Reference: HA90D Large (0.8 – 1.8 mm) 2.0 cc FDA UDI
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). FDA UDI

Identifiers

Catalog Number: HA90D20L FDA UDI
Primary DI / UDI-DI: 10810051880073 FDA UDI
510(k) Number: K202675 FDA UDI
FDA Product Code: LYC FDA UDI
GMDN Term: Synthetic bone graft FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3930 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Synthetic bone graft

InRoad® Dental Synthetic Bone Graft by Osteogene Tech Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Bicera® Resorbable Bone Substitute — Wiltrom Co., Ltd. (Chutung) · Class II
OsseoSculpt Moldable ABG, 3cc — Biogennix, LLC · Class II
Montage Settable Bone Putty — ABYRX, INC. · Class II
IngeniOS HA — curasan AG · Class II
Osbone Dental — curasan AG · Class II
Bicera® Resorbable Bone Substitute — WILTROM INC. · Class II

Cleared under the same submission

K202675 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Osteogene Tech Corp

Sources (1)

FDA UDI ad730ae3-446b-4bd7-aed4-415f93ada7a4 36 fields · synced Jun 9, 2026