InRoad® Dental Synthetic Bone Graft— 510(k) K202675

Name: FDA 510(k) clearance K202675
Creator: U.S. Food and Drug Administration
Published: 2022-03-04

Substantially Equivalent

Osteogene Tech Corp

FDA 510(k) clearance K202675 for InRoad® Dental Synthetic Bone Graft, Substantially Equivalent on 2022-03-04. Applicant: Osteogene Tech Corp. Device class: 2.

Clearance details

Applicant: Osteogene Tech Corp
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2020-09-15
Decision date: 2022-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwood, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYC

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K253317 — Cytrans Elashield2026-07-06
K253883 — Bonalive Maxillofacial2026-05-14
K251818 — BONTREE PLUS2026-03-06
K244006 — FG Bone Graft M2025-09-17
K243745 — FG Bone Graft B2025-08-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.