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Data / Medical devices / Germany / Dentaurum GmbH & Co. KG

Dentaurum GmbH & Co. KG: FDA-registered device maker in ISPRINGEN Baden-Wurttemberg, Germany, 12 510(k) clearances

Dentaurum GmbH & Co. KG is registered with the FDA (registration 9611458) in ISPRINGEN Baden-Wurttemberg, Germany. It lists 49 device types. The FDA files 12 510(k) clearances under its listings, the newest dated May 2, 2008. Registered through 2026. 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 Dentaurum GmbH & Co. KG
FDA registration number
9611458
FEI number
3002809532
Address
Turnstrasse 31, ISPRINGEN Baden-Wurttemberg, Germany, 75228
Owner or operator
Dentaurum GmbH & Co. KG (8010391)
Roles
Exporter to the US, Manufacturer
First device listed
September 2, 1980
Registered through
2026
Brand names listed
"O" TRAYS, Aligner, Attachment, Band material, Band seater, Band setter, Bar hinge, Bar sleeve and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Manufactureraccessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, ResinDYH2Exporter to the US, Manufactureraccessdata.fda.gov
Aligner, Bracket, OrthodonticECQ1Manufactureraccessdata.fda.gov
Alloy, Metal, BaseEJH2Manufactureraccessdata.fda.gov
Alloy, Other Noble MetalEJS2Manufactureraccessdata.fda.gov
Attachment, Precision, AllEGG1Manufactureraccessdata.fda.gov
Band, Elastic, OrthodonticECI1Manufactureraccessdata.fda.gov
Band, Material, OrthodonticDYO1Manufactureraccessdata.fda.gov
Band, Preformed, OrthodonticECM1Manufactureraccessdata.fda.gov
Bar, PreformedEHO1Manufactureraccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Manufactureraccessdata.fda.gov
Bracket, Plastic, OrthodonticDYW2Manufactureraccessdata.fda.gov
Bur, DentalEJL1Manufactureraccessdata.fda.gov
Clamp, Wire, OrthodonticECN1Manufactureraccessdata.fda.gov
Clasp, PreformedEHP1Manufactureraccessdata.fda.gov
Clasp, WireEJW1Manufactureraccessdata.fda.gov
Cutter, WireHXZ1Exporter to the US, Manufactureraccessdata.fda.gov
Disk, AbrasiveEHJ1Manufactureraccessdata.fda.gov
Drill, Dental, IntraoralDZA1Manufactureraccessdata.fda.gov
Driver, Band, OrthodonticECT1Exporter to the USaccessdata.fda.gov
FacebowKCR1Manufactureraccessdata.fda.gov
Forceps, Dressing, DentalEFL1Manufactureraccessdata.fda.gov
Gauge, Depth, Instrument, DentalEIL1Manufactureraccessdata.fda.gov
Guard, DiskEEJ1Manufactureraccessdata.fda.gov
Handle, Instrument, DentalEJB1Manufactureraccessdata.fda.gov
Headgear, Extraoral, OrthodonticDZB2Manufactureraccessdata.fda.gov
Implant, Endosseous, OrthodonticOAT2Manufactureraccessdata.fda.gov
Instrument, Ligature Tucking, OrthodonticECP1Exporter to the USaccessdata.fda.gov
Instruments, Dental HandDZN1Manufactureraccessdata.fda.gov
Maintainer, Space Preformed, OrthodonticDYT1Manufactureraccessdata.fda.gov
Marker, PeriodonticEMP1Manufactureraccessdata.fda.gov
Material, ImpressionELW2Manufactureraccessdata.fda.gov
Pin, Retentive And Splinting, And Accessory InstrumentsEBL1Manufactureraccessdata.fda.gov
Plier, OrthodonticJEX1Manufactureraccessdata.fda.gov
Positioner, Tooth, PreformedKMY1Manufactureraccessdata.fda.gov
Powder, PorcelainEIH2Manufactureraccessdata.fda.gov
Punch, Biopsy, SurgicalEME1Manufactureraccessdata.fda.gov
Pusher, Band, OrthodonticECS1Manufactureraccessdata.fda.gov
Reamer, Pulp Canal, EndodonticEKP1Manufactureraccessdata.fda.gov
Retainer, Screw Expansion, OrthodonticDYJ1Manufactureraccessdata.fda.gov
Retractor, All TypesEIG1Manufactureraccessdata.fda.gov
Setter, Band, OrthodonticECR1Manufactureraccessdata.fda.gov
Spring, OrthodonticECO1Manufactureraccessdata.fda.gov
Strip, Polishing AgentEHM1Manufactureraccessdata.fda.gov
Tray, Impression, PreformedEHY1Manufactureraccessdata.fda.gov
Tube, OrthodonticDZD1Manufactureraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Manufactureraccessdata.fda.gov
Wheel, Polishing AgentEJQ1Manufactureraccessdata.fda.gov
Wire, OrthodonticDZC1Manufactureraccessdata.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 2, 2008K081143BIOMERS TRANSLUCENT ORTHODONTIC WIREDYWSubstantially EquivalentBiomers Product, LLCaccessdata.fda.gov
April 15, 2005K042965TOMAS PINOATSubstantially EquivalentDentaurum, Inc.accessdata.fda.gov
November 21, 2003K030644CONTEC DUO, CONTEC LC, CONTEC LCRDYHSubstantially EquivalentDentaurumaccessdata.fda.gov
June 5, 2001K011428TRICERAMEIHSubstantially EquivalentDentaurum, Inc.accessdata.fda.gov
June 5, 2001K011425CARMENEIHSubstantially EquivalentDentaurum, Inc.accessdata.fda.gov
April 5, 1999K981036SMARTBONDDYHSubstantially EquivalentGac Intl., Inc.accessdata.fda.gov
February 13, 1995K942667DENT-O-CRYL ORTHODONTIC ACRYLICKMYSubstantially EquivalentDentauraum, Inc.accessdata.fda.gov
August 10, 1994K942666ORTHALGENAT IMPRESSION MATERIALELWSubstantially EquivalentDentauraum, Inc.accessdata.fda.gov
August 1, 1994K936151EXTRAORAL HEADGEARDZBSubstantially EquivalentDentauraum, Inc.accessdata.fda.gov
February 4, 1994K935144DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICSECISubstantially EquivalentDentauraum, Inc.accessdata.fda.gov
February 4, 1994K935140DENTAURUM STEEL LIGATURE WIRESDZCSubstantially EquivalentDentauraum, Inc.accessdata.fda.gov
February 4, 1994K935139FASCINATION CERAMIC BRACKETEJFSubstantially EquivalentDentauraum, Inc.accessdata.fda.gov

Compare with other makers

Updated May 2, 2008. 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.