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Data / Medical devices / Germany / Vita Zahnfabrik H. Rauter GMBH & Co. KG.

Vita Zahnfabrik H. Rauter GMBH & Co. KG.: FDA-registered device maker in BAD SACKINGEN Baden-Wurttemberg, Germany, 38 510(k) clearances

Vita Zahnfabrik H. Rauter GMBH & Co. KG. is registered with the FDA (registration 1000625496) in BAD SACKINGEN Baden-Wurttemberg, Germany. It lists 15 device types. The FDA files 38 510(k) clearances under its listings, the newest dated February 23, 2026. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch Vita Zahnfabrik H. Rauter GMBH & Co. KG.
FDA registration number
1000625496
FEI number
4838
Address
Spitalgasse 3, BAD SACKINGEN Baden-Wurttemberg, Germany, D-79704
Owner or operator
VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG. (9052908)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed
March 24, 2006
Registered through
2026
Brand names listed
ADIVA F–CEM, Akzent LC, Alumina Blanks Spinell Blanks Spinell Optimizer Alumina Optimizer In-Ceram Zirconia, CAD Temp, CAD Waxx, Celay Blanks Celay Optimizer, Hi-Ceram, In-Ceram AL Cube and more

Devices it lists

DeviceProduct codeClassRoleSource
Abutment, Implant, Dental, EndosseousNHA2Manufactureraccessdata.fda.gov
Additively Manufactured, Preformed, Resin Denture ToothPZY2Repackager or relabeleraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Complaint file establishment, Manufactureraccessdata.fda.gov
Coating, Filling Material, ResinEBD2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Denture, Plastic, TeethELM2Manufactureraccessdata.fda.gov
Dentures, PartialNSKNManufactureraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Point, AbrasiveEHL1Repackager or relabeleraccessdata.fda.gov
Powder, PorcelainEIH2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Protector, SilicateEFX1Manufactureraccessdata.fda.gov
Resin, Denture, Relining, Repairing, RebasingEBI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsNOF2Repackager or relabeleraccessdata.fda.gov
Teeth, PorcelainELL2Manufactureraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Manufactureraccessdata.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
February 23, 2026K251587VITA VMLC PrimerKLESubstantially EquivalentVita Zahnfabrik H. Rauter GmbH & Co. Kg.accessdata.fda.gov
February 21, 2025K243940VITA YZ Multi TranslucentEIHSubstantially EquivalentVita Zahnfabrik H.Rauter GmbH & Co.accessdata.fda.gov
September 23, 2022K222877FREEPRINT crownEBFSubstantially EquivalentDetax GmbHaccessdata.fda.gov
November 22, 2021K211854VITA Akzent LCEBDSubstantially EquivalentVita Zahnfabrik GmbH H Rauter & COaccessdata.fda.gov
November 16, 2020K200461Freeprint dentureEBISubstantially EquivalentDetax GmbH & Co. KGaccessdata.fda.gov
July 21, 2020K193434VITA LUMEX ACEIHSubstantially EquivalentVita Zahnfabrik GmbH H Rauter & COaccessdata.fda.gov
May 14, 2020K193436VITA AmbriaEIHSubstantially EquivalentVita Zahnfabrik GmbH H Rauter & COaccessdata.fda.gov
January 29, 2020K191926VITA VIONIC BondEBISubstantially EquivalentVita Zanhnfabrik H. Rauter GmbH Co.accessdata.fda.gov
November 22, 2019K190518Color Liquid, Vita LiquidEIHSubstantially EquivalentZirkonzahn Srlaccessdata.fda.gov
August 1, 2018K180703VITA YZ ST and VITA YZ XTEIHSubstantially EquivalentVita Zahnfabrik H.Rauter GmbH Co.accessdata.fda.gov
June 30, 2016K153645VITA ENAMIC Implant Solutions (IS)NHASubstantially EquivalentVita Zahnfabrik H.Rauter GmbH Co.accessdata.fda.gov
December 30, 2015K152373VITA VM LC FlowEBFSubstantially EquivalentVita Zahnfabrik H.Rauter GmbH & Co.accessdata.fda.gov
January 31, 2014K132070VITA SUPRINITY(R)EIHSubstantially EquivalentVita Zahnfabrik H.Rauter GmbH & Co.accessdata.fda.gov
March 1, 2013K123761VITA ENAMIC STAINSEBDSubstantially EquivalentInnovation Meditech GmbHaccessdata.fda.gov
December 13, 2012K122269ENAMICEIHSubstantially EquivalentVita Zahnfabrik H.Rauter GmbH & Co.accessdata.fda.gov
August 11, 2010K102128VITABLOCSEIHSubstantially EquivalentVita Zahnfabrik H.Rauter GmbH & Co.accessdata.fda.gov
December 3, 2009K093446VITA VMK MASTEREIHSubstantially EquivalentVita Zahnfabrik H. Rauter GmbH & Co. Kg.accessdata.fda.gov
June 1, 2007K070991VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310EBGSubstantially EquivalentVitaaccessdata.fda.gov
September 29, 2006K061851ZIRKONZAHN ICEEIHSubstantially EquivalentZirkonzahn GmbHaccessdata.fda.gov
April 27, 2006K060441VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98EIHSubstantially EquivalentVidentaccessdata.fda.gov
August 15, 2005K052130VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40EIHSubstantially EquivalentVidentaccessdata.fda.gov
March 15, 2005K050362VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES)EIHSubstantially EquivalentVidentaccessdata.fda.gov
October 9, 2002K022996VITA IN-CERAM YZ CUBES FOR CERECEIHSubstantially EquivalentVidentaccessdata.fda.gov
May 17, 2000K000597VITA RESPONSEEIHSubstantially EquivalentVidentaccessdata.fda.gov
March 9, 1999K990108LC FLOWFILLEBFSubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
August 2, 1998K982664VITA TITANIUM PORCELAINEIHSubstantially EquivalentVidentaccessdata.fda.gov
July 8, 1996K961434VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEMEBFSubstantially EquivalentVidentaccessdata.fda.gov
March 15, 1996K960480IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013ELLSubstantially EquivalentVidentaccessdata.fda.gov
May 2, 1995K951183IN-CERAM SPINELLEIHSubstantially EquivalentVidentaccessdata.fda.gov
March 18, 1994K934195VITA CELAY BLANKS AND VITA CELAY OPTIMIZEREIHSubstantially EquivalentVidentaccessdata.fda.gov
July 2, 1992K921623VITADUR ALPHA PORCELAINEIHSubstantially EquivalentVidentaccessdata.fda.gov
June 22, 1992K913644VITA IN-CERAMEIHSubstantially EquivalentVidentaccessdata.fda.gov
June 18, 1992K921474VITA OMEGA PORCELAINEIHSubstantially EquivalentVidentaccessdata.fda.gov
March 2, 1992K914476VITAPAN ACRYLIC DENTURE TEETHELMSubstantially EquivalentVidentaccessdata.fda.gov
October 10, 1990K901862VMK 68 AND VMK 68N DENTAL PORCELAIN KITEIHSubstantially EquivalentVidentaccessdata.fda.gov
October 5, 1990K902200VITA HI-CERAMEIHSubstantially EquivalentVidentaccessdata.fda.gov
October 5, 1990K902105VITADUR-N DENTAL PORCELAIN KITEIHSubstantially EquivalentVidentaccessdata.fda.gov
October 5, 1990K901982VITACHROM-L DENTAL PORCELAIN KITEIHSubstantially EquivalentVidentaccessdata.fda.gov

Compare with other makers

Updated February 23, 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.