Skip to the page
Get started – free

Data / Medical devices / Germany / Medentika GMBH

Medentika GMBH: FDA-registered device maker in Huegelsheim Baden-Wurttemberg, Germany, 12 510(k) clearances

Medentika GMBH is registered with the FDA (registration 3008770646) in Huegelsheim Baden-Wurttemberg, Germany. It lists 4 device types. The FDA files 12 510(k) clearances under its listings, the newest dated May 7, 2026. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Medentika GMBH
FDA registration number
3008770646
Address
Hammweg 8-10, Huegelsheim Baden-Wurttemberg, Germany, 76549
Owner or operator
INSTITUT STRAUMANN AG (9005052)
Roles
Specification developer
First device listed
June 29, 2007
Registered through
2027
Brand names listed
Abutment components, CARES® Advanced Bar, CARES® Basic Bar, CARES® Complex Bar, Custom Abutment AS, Dental Implant Accesories, HSL abutments (Castable gold abutments), MINICONE Implant and more

Devices it lists

DeviceProduct codeClassRoleSource
Abutment, Implant, Dental, EndosseousNHA2Specification developeraccessdata.fda.gov
Accessories, Implant, Dental, EndosseousNDP1Specification developeraccessdata.fda.gov
Dental Abutment Design Software For Dental LaboratoryPNP2Specification developeraccessdata.fda.gov
Implant, Endosseous, Root-FormDZE2Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 7, 2026K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueNHASubstantially EquivalentInstitut Straumann AGaccessdata.fda.gov
December 23, 2025K253341Custom Abutments ASNHASubstantially EquivalentMedentika GmbHaccessdata.fda.gov
April 22, 2025K242542Medentika CAD/CAM AbutmentsNHASubstantially EquivalentMedentika GmbHaccessdata.fda.gov
April 15, 2024K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit AbutmentsNHASubstantially EquivalentMedentika GmbHaccessdata.fda.gov
December 8, 2020K201711CARES Screw - Retained Bars and Bridges (SRBB)NHASubstantially EquivalentMedentika GmbHaccessdata.fda.gov
October 16, 2020K200906MINICONE ImplantDZESubstantially EquivalentMedentika GmbHaccessdata.fda.gov
January 6, 2020K191123Multi-unit AbutmentsNHASubstantially EquivalentMedentika GmbHaccessdata.fda.gov
September 15, 2017K170838Medentika CAD/CAM TiBasesNHASubstantially EquivalentMedentika GmbHaccessdata.fda.gov
October 23, 2015K150203Medentika CAD/CAM AbutmentsNHASubstantially EquivalentMedentika GmbHaccessdata.fda.gov
February 20, 2015K142167MEDENTIKA ABUTMENT SYSTEMNHASubstantially EquivalentMedentika GmbHaccessdata.fda.gov
February 17, 2012K111421SIRONA DENTAL CAD/CAM SYSTEMNHASubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
October 22, 2010K100152SIRONA CAD/CAM SYSTEMNHASubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov

Compare with other makers

Updated May 7, 2026. 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.