Data / Medical devices / Austria / Klema Dentalprodukte GMBH
Klema Dentalprodukte GMBH: FDA-registered device maker in Meiningen Vorarlberg, Austria, 13 510(k) clearances
Klema Dentalprodukte GMBH is registered with the FDA (registration 3005974404) in Meiningen Vorarlberg, Austria. It lists 4 device types. The FDA files 13 510(k) clearances under its listings, the newest dated March 25, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005974404
- Address
- Koblacherstrasse 3A, Meiningen Vorarlberg, Austria, 6812
- Owner or operator
- GC America Inc. (8030268)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 30, 2007
- Registered through
- 2026
- Brand names listed
- Aadva Zr Coloring Liquid, CREATION CP-ZI PORCELAIN, Creation, Creation CC, Creation LS, Creation Magic Colour, Creation ZI-CT, ZI-F, GC Aadva Zr Disk and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Teeth, Porcelain | ELL | 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 |
|---|---|---|---|---|---|---|
| March 25, 2016 | K152274 | MSCB-001 | EIH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| September 29, 2009 | K092020 | AADVA ZR COLORING LIQUID | EIH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| November 26, 2008 | K082740 | GC AADVA ZR DISK | EIH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 1, 2007 | K070114 | CREATION CP-ZI PORCELAIN | EIH | Substantially Equivalent | Jensen Industries, Inc. | accessdata.fda.gov |
| January 12, 2005 | K043468 | WILLI GELLER CREATION II PORCELAIN | EIH | Substantially Equivalent | Jensen Int'L, Inc. | accessdata.fda.gov |
| January 11, 2005 | K043201 | WILLI GELLER CREATION ZI PORCELAIN | EIH | Substantially Equivalent | Jensen Industries, Inc. | accessdata.fda.gov |
| December 20, 2004 | K043221 | WILLI GELLER CREATION CP PORCELAIN | EIH | Substantially Equivalent | Jensen Industries, Inc. | accessdata.fda.gov |
| April 22, 2004 | K040567 | GC INITIAL MC, AL AND LF | EIH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 27, 2001 | K010160 | WILLI GELLER CREAPEARL | ELM | Substantially Equivalent | Jensen Industries, Inc. | accessdata.fda.gov |
| November 6, 2000 | K002904 | WILLI GELLER CREATION AND LF PORCELAIN | EIH | Substantially Equivalent | Jensen Industries, Inc. | accessdata.fda.gov |
| August 16, 2000 | K002041 | WILLI GELLER CREATION & AV PORCELAIN | EIH | Substantially Equivalent | Jensen Industries, Inc. | accessdata.fda.gov |
| October 22, 1998 | K981490 | WILLI GELLER CREATION PORCELAIN | EIH | Substantially Equivalent | Jensen Industries, Inc. | accessdata.fda.gov |
| August 26, 1997 | K972594 | METALPRIMER II | KLE | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Powder, Porcelain
- All makers of Teeth, Porcelain
- All makers of Agent, Tooth Bonding, Resin
- All makers of Denture, Plastic, Teeth
Updated March 25, 2016. 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.