Manufacturer registered with FDA
Bausch & Lomb Incorporated
Bridgewater, NJ, United States. Lists 3 dental device types with FDA across 2 registered establishments, and holds 3 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 0
- 510(k) clearances
- 31991–1994
- Markets registered in
- 196,213 registrations outside the US
- Establishments
- 2United States
510(k) clearances per year, 1990–2026
Registered in 19 markets
Where regulators' registries name Bausch & Lomb Incorporated as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Bausch & Lomb Incorporated | 3 clearances | 1991–1994 | Below |
| Thailand | Thai FDA | Manufacturer | BAUSCH & LOMB, INC.BAUSCH & LOMB GMBH · Bausch & Lomb GmbH · +1 | 3,525 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | BAUSCH & LOMB INC.BAUSCH & LOMB GMBH · BAUSCH & LOMB INCORPORATED · +2 | 808 | 1998–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | BAUSCH & LOMB INCORPORATEDBAUSCH & LOMB INC. · BAUSCH & LOMB INC · +2 | 492 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Bausch & Lomb Inc.Bausch & Lomb, Inc. · Bausch & Lomb Incorporated · +2 | 264 | 1999–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Bausch & Lomb GmbHBausch & Lomb Incorporated | 183 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Bausch & Lomb IncorporatedBausch & Lomb GmbH · Bausch & Lomb, Incorporated | 166 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Bausch & Lomb IncorporatedBausch & Lomb GmbH | 145 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BAUSCH & LOMB INCORPORATEDBAUSCH. & LOMB INCORPORATED · BAUSCH & LOMB INC. · +2 | 139 | 1996–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BAUSCH & LOMB INC.BAUSCH & LOMB INCORPORATED · Bausch & Lomb Incorporated · +1 | 118 | 1974–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Bausch & Lomb IncBausch & Lomb GmbH | 109 | 2003–2025 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Bausch & Lomb IncorporatedBausch & Lomb GmbH | 89 | 2021–2026 | Pure Global AI |
| China | NMPA | Registration holder | 博士伦有限公司Bausch & Lomb Incorporated博士伦有限公司Bausch & Lomb GmbH · 博士伦有限公司Bausch&Lomb, Incorporated · +2 | 57 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Bausch & Lomb IncorporatedBausch & Lomb, Incorporated | 41 | 2008–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BAUSCH & LOMB INCORPORATEDBAUSCH & LOMB INC · BAUSCH & LOMB, INC · +2 | 32 | 2015–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Bausch & Lomb, INC.Bausch & Lomb Incorporated · Bausch & Lomb, Inc. · +2 | 26 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Bausch & LombBausch & Lomb Incorporated · Bausch & Lomb Inc. | 15 | — | Pure Global AI |
| Egypt | EDA | Manufacturer | Bausch & Lomb Incorporated,Bausch & Lomb,Incorporated, | 2 | 2023–2023 | Pure Global AI |
| Philippines | FDA Philippines | Registration holder | Bausch & Lomb, Inc. | 2 | 2022–2022 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Bausch & Lomb Incorporated 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 | — | 2016 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | — | 2013 |
| 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
510(k) clearances
Clearances on which FDA names Bausch & Lomb Incorporated as the applicant.
Also lists devices cleared under other names
Bausch & Lomb Incorporated 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), Colbar Lifescience , Ltd. (1).
| 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 |
| 22 Feb 2006 | K053260 | OSSIX -PLUS | Colbar Lifescience , Ltd. | NPL Intraoral Animal Source Barrier |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Bausch & Lomb IncorporatedFDA reg. 1313525 | Rochester, NY, United States | Complaint file establishment |
| Bausch & Lomb IncorporatedFDA reg. 1932180 | Manchester, MO, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9913003). 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.