Dental Device Guide
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Not currently registered with FDA under this name

Orthogen, LLC

Springfield, NJ, United States. Named as applicant on 2 dental 510(k) clearances between 2001 and 2011. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
22001–2011
Markets registered in
1United States
Establishments
0—
2001: 12011: 1200020102020

510(k) clearances per year, 2000–2026

510(k) clearances

Clearances on which FDA names Orthogen, LLC as the applicant.

Decided510(k)DeviceDevice type
6 May 2011K102208NANOGENLYC Synthetic Bone Grafting Material
11 Sep 2001K011403SURGIPLASTER CALCIUM SULFATE HEMIHYDRATELYC Synthetic Bone Grafting Material

Sources

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 of the most recent filing, which can be a US agent.