Data / Medical devices / Germany / Sycotec GMBH & Co KG
Sycotec GMBH & Co KG: FDA-registered device maker in Leutkirch Baden-Wurttemberg, Germany, 3 510(k) clearances
Sycotec GMBH & Co KG is registered with the FDA (registration 3009302876) in Leutkirch Baden-Wurttemberg, Germany. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 31, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009302876
- Address
- Wangener Strasse 78, Leutkirch Baden-Wurttemberg, Germany, 88299
- Owner or operator
- SYCOTEC GMBH & CO KG (10047093)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- June 27, 2014
- Registered through
- 2026
- Brand names listed
- A-dec XC10 Electric Motor, E-SANAO Advantage, E-SANAO Prep, E-STATIS Advantage, E-STATIS Prep, ETorque Handpieces, Midwest E Attachments, Midwest E Electric Handpiece System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Controller, Foot, Handpiece And Cord | EBW | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Handpiece, Air-Powered, Dental | EFB | 1 | Contract manufacturer, Specification developer | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| January 31, 2014 | K132356 | SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST | EGS | Substantially Equivalent | Scican GmbH | accessdata.fda.gov |
| July 24, 2009 | K090937 | E-STATIS 40 SYSTEM | EBW | Substantially Equivalent | Scican , Ltd. | accessdata.fda.gov |
| October 19, 2006 | K062418 | K-SPRAY, MODEL 085-2715 | EFB | Substantially Equivalent | Scican | accessdata.fda.gov |
Compare with other makers
- All makers of Handpiece, Air-Powered, Dental
- All makers of Controller, Foot, Handpiece And Cord
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
Updated January 31, 2014. 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.