Manufacturer registered with FDA
Schutz Dental GmbH
ROSBACH, HESSEN, Germany. Lists 6 dental device types with FDA across 1 registered establishment, and holds 7 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 5
- 510(k) clearances
- 72005–2016
- Markets registered in
- 11159 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2000–2026
Registered in 11 markets
Where regulators' registries name Schutz 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 | Schutz Dental GmbH | 7 clearances | 2005–2016 | Below |
| South Korea | MFDS | Manufacturer | Schutz Dental GmbHSchutz Dental · Schutz-Dental · +2 | 59 | 1998–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Schutz Dental GmbH | 35 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Schütz Dental GmbH | 34 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Schütz Dental GmbH | 11 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | SCHUETZ DENTAL GMBH | 9 | 2009–2009 | Pure Global AI |
| Israel | AMAR | Manufacturer | Schutz Dental GmbH | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SCHUTZ DENTAL GMBH | 3 | 2008–2016 | Pure Global AI |
| Australia | TGA | Manufacturer | Schutz-Dental GmbH | 2 | 2020–2020 | Pure Global AI |
| Egypt | EDA | Manufacturer | Schutz Dental GmbH,Schütz Dental GmbH, | 2 | 2026–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SCHUTZ DENTAL GMBH | 1 | 2011–2011 | 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 Schutz 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 | — | 2015 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | — | 2006 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Lister | — | 2020 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | — | 2006 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | — | 1984 |
| Jaw Tracking Device for Monitoring Jaw PositionsNFS · Class 1 | — | Lister | Alignment Spoon (Alignment Fork)Bite Fork Adapter UNBite Fork UNJMA OpticTizian JMA Optic | 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 Schutz Dental GmbH as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 24 Oct 2016 | K151399 | Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow | EBF Resin Tooth Shade Material |
| 4 Aug 2016 | K152471 | CAPO BULK FILL | EBF Resin Tooth Shade Material |
| 12 Feb 2015 | K133268 | TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS | EBG Resin Temporary Crown and Bridge |
| 24 Aug 2007 | K071010 | TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS | EIH Porcelain Powder |
| 26 Oct 2005 | K052073 | FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000 | EBI Rebasing Repairing Relining Denture Resin |
| 17 Oct 2005 | K052189 | REVENEER CERAMIC REPAIR SYSTEM | KLE Resin Tooth Bonding Agent |
| 29 Jun 2005 | K051050 | SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092 | KLE Resin Tooth Bonding Agent |
Some of these clearances are listed with FDA today by another company: 3D Dental Designs and Development LLC (1), anax dent GmbH (1).
Also lists devices cleared under other names
Schutz Dental GmbH 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: Xceramusa (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SCHUETZ DENTAL GMBHFDA reg. 8010711 | ROSBACH Hesse, Germany | Foreign exporter, Manufacturer |
Other names on FDA records
Schuetz Dental GmbH
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010711). 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.