Data / Medical devices / Germany / Schuetz Dental GMBH
Schuetz Dental GMBH: FDA-registered device maker in ROSBACH Hesse, Germany, 4 510(k) clearances
Schuetz Dental GMBH is registered with the FDA (registration 8010711) in ROSBACH Hesse, Germany. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 12, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8010711
- FEI number
- 7300
- Address
- Dieselstrasse 5-6, ROSBACH Hesse, Germany, D-61191
- Owner or operator
- SCHUTZ DENTAL GMBH (8010711)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- September 25, 1984
- Registered through
- 2026
- Brand names listed
- Alignment Spoon (Alignment Fork), Bite Fork Adapter UN, Bite Fork UN, JMA Optic, Tizian JMA Optic
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Alloy, Metal, Base | EJH | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Device, Jaw Tracking, For Monitoring Jaw Positions | NFS | 1 | Exporter to the US | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Exporter to the US | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 12, 2015 | K133268 | TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS | EBG | Substantially Equivalent | Schutz-Dental GmbH | accessdata.fda.gov |
| April 8, 2010 | K100250 | XCERAM | EIH | Substantially Equivalent | Xceramusa | accessdata.fda.gov |
| October 26, 2005 | K052073 | FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000 | EBI | Substantially Equivalent | Schutz-Dental GmbH | accessdata.fda.gov |
| June 29, 2005 | K051050 | SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092 | KLE | Substantially Equivalent | Schutz-Dental GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Powder, Porcelain
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Agent, Tooth Bonding, Resin
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Alloy, Metal, Base
- All makers of Device, Jaw Tracking, For Monitoring Jaw Positions
Updated February 12, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.