Registered with FDA

Bausch Health US LLC

Bridgewater, NJ, United States. Lists 2 dental device types with FDA across 1 registered establishment.

FDA owner/operator10039156

Device types listed: 2
Brands and models: 0
510(k) clearances: 0as applicant
Markets registered in: 1United States
Establishments: 1United States

Devices listed with FDA

What Bausch Health US LLC currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Intraoral Animal Source BarrierNPL · Class 2	Bone grafts & membranes	Lister	—	2022
Animal Source Bone Grafting MaterialNPM · Class 2	Bone grafts & membranes	Lister	—	2018

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

Also lists devices cleared under other names

Bausch Health US LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Datum Dental, Ltd. (3).

Decided	510(k)	Device	Applicant	Device type
18 Jul 2017	K163714	OSSIX BONE	Datum Dental, Ltd.	NPM Animal Source Bone Grafting Material
4 Aug 2016	K160281	OSSIX PLUS	Datum Dental, Ltd.	NPL Intraoral Animal Source Barrier
4 Aug 2016	K153549	OSSIX VOLUMAX	Datum Dental, Ltd.	NPL Intraoral Animal Source Barrier

Registered establishments

Establishment	Location	What it does
Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International)FDA reg. 3009443653	Bridgewater, NJ, United States	Complaint file establishment

Other names on FDA records

Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International)

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10039156). 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.