Cleared Traditional

InRoad? Dental Synthetic Bone Graft

K202675 · Osteogene Tech Corp · Dental

Mar 2022

Decision

535d

Days

Class 2

Risk

About This 510(k) Submission

K202675 is an FDA 510(k) clearance for the InRoad? Dental Synthetic Bone Graft, a Bone Grafting Material, Synthetic (Class II — Special Controls, product code LYC), submitted by Osteogene Tech Corp (Norwood, US). The FDA issued a Cleared decision on March 4, 2022, 535 days after receiving the submission on September 15, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K202675 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 15, 2020
Decision Date	March 04, 2022
Days to Decision	535 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	LYC — Bone Grafting Material, Synthetic
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3930
Definition	A Synthetic Bone Grafting Material Is Synthetically-derived Device, Such As Hydroxylapatite, Intended To Fill, Augment, Or Reconstruct Periodontal And Or Bony Defects Of The Upper Or Lower Jaw.