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Data / Medical devices / United States / Straumann Manufacturing, Inc.

Straumann Manufacturing, Inc.: FDA-registered device maker in Mansfield, TX, United States, 27 510(k) clearances

Straumann Manufacturing, Inc. is registered with the FDA (registration 3024185724) in Mansfield, TX, United States. It lists 10 device types. The FDA files 27 510(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 Straumann Manufacturing, Inc.
FDA registration number
3024185724
Address
1961 Heritage Parkway, Mansfield, TX, United States, 76063
Owner or operator
INSTITUT STRAUMANN AG (9005052)
Roles
Contract manufacturer, Manufacturer
First device listed
June 29, 2007
Registered through
2027
Brand names listed
CARES Abutment, CARES TAN Abutment, CARES® Advanced Bar, CARES® Basic Bar, CARES® Complex Bar, Custom Abutment AS, Dental Implant Accesories, MedentiBase Titaniumbase abutment and more

Devices it lists

DeviceProduct codeClassRoleSource
Abutment, Implant, Dental, EndosseousNHA2Contract manufacturer, Manufactureraccessdata.fda.gov
Accessories, Implant, Dental, EndosseousNDP1Manufactureraccessdata.fda.gov
Alloy, Metal, BaseEJH2Contract manufactureraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Contract manufactureraccessdata.fda.gov
Dental Abutment Design Software For Dental LaboratoryPNP2Contract manufacturer, Manufactureraccessdata.fda.gov
Driver, Wire, And Bone Drill, ManualDZJ2Manufactureraccessdata.fda.gov
Implant, Endosseous, Root-FormDZE2Contract manufacturer, Manufactureraccessdata.fda.gov
Powder, PorcelainEIH2Contract manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Manufactureraccessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsNOF2Contract manufactureraccessdata.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
August 18, 2025K250271Neodent Implant System - Zirconia Implant SystemDZESubstantially EquivalentJJGC Indústria e Comércio de Materiais Dentários S.A.accessdata.fda.gov
May 27, 2025K250614Neodent Implant System - Custom AbutmentsNHASubstantially EquivalentJjgc Indústria E Comércia DE Materiais Dentários S.A.accessdata.fda.gov
February 21, 2025K243278Custom AbutmentsNHASubstantially EquivalentInstitut Straumann AGaccessdata.fda.gov
December 4, 2024K242686Neodent Implant SystemNHASubstantially EquivalentJjgc Indústria E Comércia DE Materiais Dentários S.A.accessdata.fda.gov
May 2, 2024K233857Neodent Implant System – Custom AbutmentsNHASubstantially EquivalentJJGC Indústria e Comércio de Materiais Dentários S.A.accessdata.fda.gov
April 15, 2024K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit AbutmentsNHASubstantially EquivalentMedentika GmbHaccessdata.fda.gov
June 21, 2021K193301coDiagnostiXDZJSubstantially EquivalentDental Wings GmbHaccessdata.fda.gov
December 8, 2020K201711CARES Screw - Retained Bars and Bridges (SRBB)NHASubstantially EquivalentMedentika GmbHaccessdata.fda.gov
August 20, 2020K200586Straumann TLX Implant SystemDZESubstantially EquivalentInstitut Straumann AGaccessdata.fda.gov
June 26, 2019K190097Straumann CARES Screw-Retained Bridges and BarsNHASubstantially EquivalentInstitut Straumann AGaccessdata.fda.gov
April 8, 2019K190040Straumann BLX Line Extension - New AbutmentsNHASubstantially EquivalentInstitut Straumann AGaccessdata.fda.gov
July 17, 2018K173968Straumann Variobase for Bridge/Bar CylindricalNHASubstantially EquivalentInstitut Straumann AGaccessdata.fda.gov
June 5, 2018K173961Straumann BLX Implant SystemDZESubstantially EquivalentInstitut Straumann AGaccessdata.fda.gov
March 30, 2018K173379Straumann Variobase for Crown ASNHASubstantially EquivalentInstitut Straumann AGaccessdata.fda.gov
January 3, 2018K172798Straumann CARES Abutments CoCrNHASubstantially EquivalentInstitut Straumann AGaccessdata.fda.gov
September 15, 2017K170838Medentika CAD/CAM TiBasesNHASubstantially EquivalentMedentika GmbHaccessdata.fda.gov
April 15, 2016K153624Neodent Implant SystemNHASubstantially EquivalentJjgc Industria E Comercio DE Materiais Dentarios Saccessdata.fda.gov
October 23, 2015K150203Medentika CAD/CAM AbutmentsNHASubstantially EquivalentMedentika GmbHaccessdata.fda.gov
July 13, 2015K150367Neodent Implant SystemNHASubstantially EquivalentJjgc Industria E Comercio DE Materiais Dentarios Saccessdata.fda.gov
August 14, 2014K140737STRAUMANN CARES SCREW RETAINED BARS/BRIDGENHASubstantially EquivalentStraumann USA, LLCaccessdata.fda.gov
April 17, 2014K133421STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREWNHASubstantially EquivalentStraumann USA, LLCaccessdata.fda.gov
October 1, 2008K082764STRAUMANN WN CARES TITANIUM ABUTMENTNHASubstantially EquivalentInstitut Straumann AGaccessdata.fda.gov
May 2, 2008K081005P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTSNHASubstantially EquivalentInstitut Straumann AGaccessdata.fda.gov
September 11, 2007K072151P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTSNHASubstantially EquivalentStraumann USAaccessdata.fda.gov
January 3, 2006K052272STRAUMANN COMPUTER AIDED RESTORATION SERVICENHASubstantially EquivalentStraumann USAaccessdata.fda.gov
May 24, 2004K041295RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANTNHASubstantially EquivalentInstitut Straumann AGaccessdata.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.