Manufacturer registered with FDA

Osteogene Tech Inc.

Norwood, NJ, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10084587Manufacturer1 clearance in five years

Device types listed: 1
Brands and models: 1
510(k) clearances: 12022–2022
Markets registered in: 1United States
Establishments: 1United States

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Osteogene Tech Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Synthetic Bone Grafting MaterialLYC · Class 2	Bone grafts & membranes	Maker	InRoad Synthetic Bone Graft	2022

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Osteogene Tech Inc. as the applicant.

Decided	510(k)	Device	Device type
4 Mar 2022	K202675	InRoad® Dental Synthetic Bone Graft	LYC Synthetic Bone Grafting Material

Registered establishments

Establishment	Location	What it does
OSTEOGENE TECH CORPFDA reg. 3021912300	Norwood, NJ, United States	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10084587). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.