Manufacturer registered with FDA
Merz Dental GmbH
LUETJENBURG, Germany. Lists 7 dental device types with FDA across 1 registered establishment, and holds 8 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 28
- 510(k) clearances
- 82003–2017
- Markets registered in
- 663 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2000–2026
Registered in 6 markets
Where regulators' registries name Merz Dental GmbH 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 | Merz Dental GmbH | 8 clearances | 2003–2017 | Below |
| Canada | Health Canada | Registration holder | MERZ DENTAL GMBH | 53 | 2003–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Merz Dental | 7 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Merz Dental GmbH | 1 | 2013–2013 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Merz Dental GmbH | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MERZ DENTAL GMBH | 1 | 2008–2008 | 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 Merz Dental GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | artBloc TempCeramill TempCoritec PMMA DiscM-PM Disc (Pink)M-PM Disc (tooth-colored)Merz Dental PMMA DiscPEEK Biosolution | 2007 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | M-PM Disc (Pink)PremEco Line Prothetic Color SystemPromoluxPromolux HIWeropress | 2014 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | artegral HDartegral, Polystar Selection | 2007 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | PEEK Biosolution | 2018 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | M-PRINT Surgical guide HTM-Print TrayM-Print TryIn | 2022 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | PremEco Line set-up wax | 2020 |
| Denture Preformed (Partially Prefabricated Denture)EKO · Class 2 | Denture resins & teeth | Maker | Baltic Denture SystemBD CreatorBD Creator plusBD Key (Upper & Lower Key)BD Key ConnectBD Key LockBD Key Plane & FinBD Key PMMABD Load | 2016 |
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 Merz Dental GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 18 Dec 2017 | K173124 | PEEK Biosolution | EBF Resin Tooth Shade Material |
| 15 Sep 2014 | K140758 | M-PM-DISC (PINK) | EBI Rebasing Repairing Relining Denture Resin |
| 22 Aug 2013 | K130076 | PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS | EBI Rebasing Repairing Relining Denture Resin |
| 21 May 2012 | K120404 | MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH | ELM Teeth Plastic Denture |
| 2 May 2008 | K080556 | ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES | EBG Resin Temporary Crown and Bridge |
| 21 Aug 2007 | K071548 | WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED | EBG Resin Temporary Crown and Bridge |
| 13 Sep 2006 | K061809 | ARTEGRAL IMCROWN | EBG Resin Temporary Crown and Bridge |
| 7 May 2003 | K030588 | ARTEGRAL AND POLYSTAR SELECTION | ELM Teeth Plastic Denture |
Some of these clearances are listed with FDA today by another company: Institut Straumann AG (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MERZ DENTAL GMBHFDA reg. 3004086252 | LUETJENBURG Schleswig-Holstein, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9055243). 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.