Manufacturer registered with FDA
Hager & Werken
DUISBURG, Germany. Lists 17 dental device types with FDA across 1 registered establishment.
- Device types listed
- 17
- Brands and models
- 20
- 510(k) clearances
- 0as applicant
- Markets registered in
- 27 registrations outside the US
- Establishments
- 1Germany
Registered in 2 markets
Where regulators' registries name Hager & Werken 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 | Hager & Werken | 17 device types | — | Below |
| South Korea | MFDS | Manufacturer | Hager&WerkenHager & Werken · Hager & Werken GmbH Co. KG | 7 | 2003–2010 | 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 Hager & Werken currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | PERFECT SPLINT | 2006 |
| Roll CottonEFN · Class 1 | — | Lister | COTTON CLIPS II | 2002 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | Happy Morning Toothbrush | 2023 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | MIRAJECT ENDO RINSE | 2004 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Spandex, cheek retractor, Mirahold cheek retractor | 2011 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | MIRA COMPO , COMPO BRUSH | 2011 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Maker | Rubber Dam | 2012 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | SMOCLEAN | 2003 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | COMPO BLITZ | 2011 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | PREPOMETER | 2004 |
| Posterior with Metal Insert Artificial TeethELJ · Class 1 | — | Lister | OCCLU PRINT | 2002 |
| Dental CementEMA · Class 2 | Dental cements | Maker | RESO PAC | 2006 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | MIRAFLOSS | 2006 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | PIC-BRUSHROTOPROX | 2003 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | RFECT PLAST KIT | 2003 |
| Dental Stain EraserMAU · Class 1 | — | Maker | MIRAWHITE PRO | 2006 |
| Dental Hygiene KitNXZ · Class 1 | — | Maker | TONG CLIN GELTONG CLIN SETTONG GEL | 2007 |
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
Hager & Werken 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: Hager Worldwide, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 May 2005 | K050658 | RESO-PAC PERIODONTAL DRESSING | Hager Worldwide, Inc. | EMA Dental Cement |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HAGER & WERKEN GMBHFDA reg. 3003487388 | DUISBURG,DE-NOTA Hamburg, Germany | Complaint file establishment, Contract manufacturer, Foreign exporter, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9050764). 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.