Manufacturer registered with FDA
Dsm Biomedical
Exton, PA, United States. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 4
- Brands and models
- 5
- 510(k) clearances
- 12020–2020
- Markets registered in
- 771 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Dsm Biomedical 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 | Dsm Biomedical | 1 clearances | 2020–2020 | Below |
| European Union | EUDAMED | Manufacturer | DSM Biomedical, Inc. | 48 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | DSM BIOMEDICALDSM BIOMEDICAL, INC. | 12 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | DSM Biomedical, Inc.DSM Biomedical | 6 | 2010–2013 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DSM BIOMEDICAL, INC. | 2 | 2024–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DSM Biomedical, Inc. | 2 | 2009–2012 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | DSM Biomedical | 1 | — | 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 Dsm Biomedical 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 | Maker | DSM Biomedical Porcine Pericardium Dental MembraneMeso Dental Membrane | 2009 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | Epi-Guide Bioresorb Barrier Matrix | 2007 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Maker | DSM Dental Bone GraftDSM Dental Bone Graft Plus | 2017 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | — | 2011 |
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 Dsm Biomedical as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 10 Sep 2020 | K193212 | DSM Biomedical Dental Bone Graft Plus | NPM Animal Source Bone Grafting Material |
Some of these clearances are listed with FDA today by another company: Young Innovations Inc (1).
Also lists devices cleared under other names
Dsm Biomedical 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: Kensey Nash Corporation Dba Dsm Biomedical (2), Kensey Nash Corporation (2), Thm Biomedical, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 May 2017 | K170245 | DSM Biomedical Dental Bone Graft | Kensey Nash Corporation Dba Dsm Biomedical | NPM Animal Source Bone Grafting Material |
| 7 Jun 2016 | K160474 | DSM Biomedical Porcine Pericardium Dental Membrane | Kensey Nash Corporation Dba Dsm Biomedical | NPL Intraoral Animal Source Barrier |
| 11 Jul 2013 | K121310 | MESOTHELIUM DENTAL MEMBRANE | Kensey Nash Corporation | NPL Intraoral Animal Source Barrier |
| 2 Oct 2009 | K090919 | KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE | Kensey Nash Corporation | NPL Intraoral Animal Source Barrier |
| 15 Oct 1996 | K940643 | OSMED EPI-GUIDE | Thm Biomedical, Inc. | LYC Synthetic Bone Grafting Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DSM Biomedical, Inc.FDA reg. 2530154 | EXTON, PA, United States | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9020253). 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.