Not currently registered with FDA under this name

American Custom Medical, Inc.

Bozeman, MT, United States. Named as applicant on 3 dental 510(k) clearances between 1994 and 1997. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 31994–1997
Markets registered in: 1United States
Establishments: 0—

510(k) clearances per year, 1990–2026

510(k) clearances

Clearances on which FDA names American Custom Medical, Inc. as the applicant.

Decided	510(k)	Device	Device type
30 Apr 1997	K965205	TEFGEN - LS	NPK Intraoral Synthetic Barrier
10 Feb 1997	K964656	TEFGEN GUIDED TISSUE MEMBRANE	NPK Intraoral Synthetic Barrier
15 Aug 1994	K935137	TEFGEN-FD	NPK Intraoral Synthetic Barrier

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.