Data / Medical devices / Germany / Yeti Dentalprodukte GMBH
Yeti Dentalprodukte GMBH: FDA-registered device maker in Engen Baden-Wurttemberg, Germany, 1 510(k) clearance
Yeti Dentalprodukte GMBH is registered with the FDA (registration 3006235664) in Engen Baden-Wurttemberg, Germany. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 15, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006235664
- Address
- Industriestr. 3-a, Engen Baden-Wurttemberg, Germany, 78234
- Owner or operator
- YETI Dentalprodukte GmbH (10034246)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 17, 2010
- Registered through
- 2026
- Brand names listed
- Lot (Solder) Universal, Solibond C plus, Solibond N, Solidur CoCr, lot
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alloy, Metal, Base | EJH | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| November 15, 2018 | K173971 | K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent | EIH | Substantially Equivalent | Yeti Dentalprodukte GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Impression Tray, Resin
- All makers of Wax, Dental, Intraoral
- All makers of Powder, Porcelain
- All makers of Mirror, Mouth
- All makers of Alloy, Metal, Base
Updated November 15, 2018. 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.