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Data / Medical devices / Germany / Voco GMBH

Voco GMBH: FDA-registered device maker in CUXHAVEN Lower Saxony, Germany, 97 510(k) clearances

Voco GMBH is registered with the FDA (registration 8010908) in CUXHAVEN Lower Saxony, Germany. It lists 41 device types. The FDA files 97 510(k) clearances under its listings, the newest dated May 1, 2026. 3 recall events name it as the recalling firm. 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 Voco GMBH
FDA registration number
8010908
FEI number
3002718942
Address
Anton-Flettner-Strasse 1-3, CUXHAVEN Lower Saxony, Germany, D-27472
Owner or operator
VOCO GMBH (8010908)
Roles
Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer
First device listed
October 7, 1994
Registered through
2027
Brand names listed
AC Activator, AC Applicator, Admira, Admira Bond, Admira Caps, Admira Flow, Admira Fusion, Admira Fusion 5 and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Repackager or relabeleraccessdata.fda.gov
Activator, Ultraviolet, For PolymerizationEBZ2Exporter to the US, Foreign private label distributor, Repackager or relabeleraccessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, ResinDYH2Manufactureraccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Manufactureraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Manufactureraccessdata.fda.gov
Amalgamator, Dental, Ac-PoweredEFD1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Cement, DentalEMA2Manufactureraccessdata.fda.gov
Coating, Filling Material, ResinEBD2Manufactureraccessdata.fda.gov
Composite Resin WarmerQGO1Exporter to the USaccessdata.fda.gov
Cord, RetractionMVLUManufactureraccessdata.fda.gov
Crown And Bridge, Long-Term Temporary, ResinPOW2Manufactureraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Manufactureraccessdata.fda.gov
Cusp, PreformedEHQ1Manufactureraccessdata.fda.gov
Dental Barriers And SleevesPEM2Repackager or relabeleraccessdata.fda.gov
Denture, Plastic, TeethELM2Manufactureraccessdata.fda.gov
Disk, AbrasiveEHJ1Manufactureraccessdata.fda.gov
Drill, Dental, IntraoralDZA1Repackager or relabeleraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Manufactureraccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Manufactureraccessdata.fda.gov
Handle, Instrument, DentalEJB1Repackager or relabeleraccessdata.fda.gov
Heat Source For Bleaching TeethEEG1Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Liner, Cavity, Calcium HydroxideEJK2Manufactureraccessdata.fda.gov
Maintainer, Space Preformed, OrthodonticDYT1Repackager or relabeleraccessdata.fda.gov
Material, ImpressionELW2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Material, Impression Tray, ResinEBH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Manufactureraccessdata.fda.gov
Mouthguard, PrescriptionMQCUManufacturer, Repackager or relabeleraccessdata.fda.gov
Plate, Base, ShellacEEA1Manufactureraccessdata.fda.gov
Point, AbrasiveEHL1Repackager or relabeleraccessdata.fda.gov
Positioner, Tooth, PreformedKMY1Exporter to the US, Manufactureraccessdata.fda.gov
Post, Root CanalELR1Repackager or relabeler, Specification developeraccessdata.fda.gov
Resin, Denture, Relining, Repairing, RebasingEBI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Resin, Root Canal FillingKIF2Manufactureraccessdata.fda.gov
Retainer, Screw Expansion, OrthodonticDYJ1Repackager or relabeleraccessdata.fda.gov
Sealant, Pit And Fissure, And ConditionerEBC2Manufactureraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Repackager or relabeleraccessdata.fda.gov
Tray, Impression, PreformedEHY1Manufactureraccessdata.fda.gov
Varnish, CavityLBH2Manufactureraccessdata.fda.gov
Warmer, Anesthetic TubeEFC1Repackager or relabeleraccessdata.fda.gov
Zinc Oxide EugenolEMB1Manufactureraccessdata.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 1, 2026K252073VOCO Profluorid Varnish + BioMinLBHSubstantially EquivalentVoco GmbHaccessdata.fda.gov
April 27, 2026K261357Grandio disc multicolorEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
March 20, 2026K252606Bifix Veneer LC, Bifix Veneer Try-InEMASubstantially EquivalentVoco GmbHaccessdata.fda.gov
July 3, 2025K251390MTA vptKIFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
May 21, 2025K251239GrandioSO UnlimitedEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
December 1, 2023K231817AlignerFlow LCDYHSubstantially EquivalentVoco GmbHaccessdata.fda.gov
July 31, 2023K231591V-Print c&b tempPOWSubstantially EquivalentVoco GmbHaccessdata.fda.gov
July 13, 2023K230877Admira Fusion 5EBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
June 23, 2023K230410DD medical polymers (PMMA)EBISubstantially EquivalentDental Direkt GmbHaccessdata.fda.gov
December 8, 2022K220826LED Curing LightEBZSubstantially EquivalentFoshan Coxo Medical Instrument Co., Ltd.accessdata.fda.gov
September 21, 2022K220236V-Print dentbaseEBISubstantially EquivalentVoco GmbHaccessdata.fda.gov
August 23, 2022K220640Bifix Hybrid Abutment CementEMASubstantially EquivalentVoco GmbHaccessdata.fda.gov
July 5, 2022K220743CediTECEBISubstantially EquivalentVoco GmbHaccessdata.fda.gov
December 9, 2021K213149VOCO Retraction PasteMVLSubstantially EquivalentVoco GmbHaccessdata.fda.gov
November 6, 2020K201091V-Print splintMQCSubstantially EquivalentVoco GmbHaccessdata.fda.gov
September 9, 2020K201090Structur CADEBGSubstantially EquivalentVoco GmbHaccessdata.fda.gov
August 26, 2020K201856Provicol QM AestheticEMASubstantially EquivalentVoco GmbHaccessdata.fda.gov
July 8, 2020K201307VisCalorEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
March 27, 2020K200294GrandioSO Light FlowEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
September 10, 2019K190484BH Medical Dental Barrier Sleeves and Barrier FilmPEMSubstantially EquivalentBh Medical Products Co., Ltd.accessdata.fda.gov
April 11, 2019K190453VisCalor bulkEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
March 1, 2019K183147BrackFixDYHSubstantially EquivalentVoco GmbHaccessdata.fda.gov
August 22, 2018K181312GrandioSO x-traEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
May 8, 2018K180386Meron Plus QMEMASubstantially EquivalentVoco GmbHaccessdata.fda.gov
November 15, 2017K171815Registrado ScanEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
August 10, 2017K171200Grandio blocsEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
June 29, 2017K170896Admira Fusion x-baseEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
September 15, 2016K161630Provicol QM PlusEMBSubstantially EquivalentVoco GmbHaccessdata.fda.gov
August 3, 2016K160774IonoStar PlusEMASubstantially EquivalentVoco GmbHaccessdata.fda.gov
July 29, 2016K153493Clip FlowEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
June 30, 2016K153177Admira Fusion FlowEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
October 20, 2015K151956Admira Fusion x-traEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
July 2, 2015K150784Admira FusionEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
May 1, 2015K143212Bifix TempEMASubstantially EquivalentVoco GmbHaccessdata.fda.gov
January 7, 2015K143486Ufi Gel hard CEBISubstantially EquivalentVoco GmbHaccessdata.fda.gov
October 20, 2014K140993IONOSTAR MOLAREMASubstantially EquivalentVoco GmbHaccessdata.fda.gov
August 1, 2014K141610FUTURABOND M+KLESubstantially EquivalentVoco GmbHaccessdata.fda.gov
February 11, 2014K130485CONTROL SEALEBCSubstantially EquivalentVoco GmbHaccessdata.fda.gov
August 14, 2013K130421MERON APPLICATION CAPSULESEMASubstantially EquivalentVoco GmbHaccessdata.fda.gov
June 20, 2013K130486FUTURABOND UNIVERSALKLESubstantially EquivalentVoco GmbHaccessdata.fda.gov
December 21, 2012K123773X-TRA BASEEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
June 1, 2012K120779STRUCTUR 3EBGSubstantially EquivalentVoco GmbHaccessdata.fda.gov
December 21, 2011K113563N-HYBRIDE-COMPOSITE LCEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
December 21, 2011K113444N-HYBRIDE-COMPOSITE LC FLOWEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
November 8, 2011K112447GRANDIO CORE DUAL CUREEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
October 20, 2011K112374X-TRA BASEEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
May 4, 2011K110440QUICK UPEBISubstantially EquivalentVoco GmbHaccessdata.fda.gov
March 28, 2011K110050FIT TEST C&BELWSubstantially EquivalentVoco GmbHaccessdata.fda.gov
January 21, 2011K103580GRANDIO SO FLOWEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
November 8, 2010K102354GRANDIO SO HEAVY FLOWEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
November 2, 2010K102351GRANDIO SOEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
October 29, 2010K102347GRANDTECEBISubstantially EquivalentVoco GmbHaccessdata.fda.gov
October 21, 2010K101104REMIN PROEJRSubstantially EquivalentVoco GmbHaccessdata.fda.gov
October 8, 2010K102450IONOLUX PROEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
August 19, 2010K101213GRANDIO FLOWEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
July 23, 2009K091894TEMPORARY C&B COMPOSITEEBGSubstantially EquivalentVoco GmbHaccessdata.fda.gov
July 23, 2009K090817IONOLUXEMASubstantially EquivalentVoco GmbHaccessdata.fda.gov
June 17, 2009K090843AMARIS GINGIVA OPAQUEREBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
February 13, 2009K083438BIFIX SEEMASubstantially EquivalentVoco GmbHaccessdata.fda.gov
January 12, 2009K083036VOCO PROFLUORID LLBHSubstantially EquivalentVoco GmbHaccessdata.fda.gov
November 24, 2008K082753FUTURABOND M/FUTURABOND M SINGLE DOSEKLESubstantially EquivalentVoco GmbHaccessdata.fda.gov
October 24, 2008K082285EASY GLAZEEBDSubstantially EquivalentVoco GmbHaccessdata.fda.gov
September 8, 2008K082560PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACTELWSubstantially EquivalentKettenbach GmbH & Co. KGaccessdata.fda.gov
July 24, 2008K080814VOCO PROFLUORID VARNISHLBHSubstantially EquivalentVoco GmbHaccessdata.fda.gov
June 7, 2007K070723FUTURABOND DC/SINGLE DOSEKLESubstantially EquivalentVoco GmbHaccessdata.fda.gov
June 5, 2007K071386AMARIS/AMARIS FLOWEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
January 22, 2007K063604TWINKY STAR NFEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
January 12, 2007K063554MERON PLUSEMASubstantially EquivalentVoco GmbHaccessdata.fda.gov
December 15, 2006K062345CERAMIC BONDEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
October 2, 2006K062344GRANDIO SEALEBCSubstantially EquivalentVoco GmbHaccessdata.fda.gov
July 21, 2006K061823ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSEEBCSubstantially EquivalentVoco GmbHaccessdata.fda.gov
June 23, 2006K061395CALSET COMPOSITE HEATEREBZSubstantially EquivalentAddent, Inc.accessdata.fda.gov
May 25, 2006K060893MODIFICATION TO REBILDA DCEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
May 2, 2006K060894BIFIX QMEMASubstantially EquivalentVoco GmbHaccessdata.fda.gov
February 15, 2006K053391X-TRA FILEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
December 15, 2005K053392FUTURABOND NR SINGLE DOSEKLESubstantially EquivalentVoco GmbHaccessdata.fda.gov
July 27, 2005K051868GRANDIO FLOWEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
July 27, 2005K051867GRANDIOEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
June 28, 2005K051535MODIFICATION TO:REGISTRADO X-TRAELWSubstantially EquivalentVoco GmbHaccessdata.fda.gov
November 1, 2004K042670FUTURABOND NRKLESubstantially EquivalentVoco GmbHaccessdata.fda.gov
April 7, 2004K040769STRUCTUR 2 SCEBGSubstantially EquivalentVoco GmbHaccessdata.fda.gov
October 21, 2003K032465MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINIEBZSubstantially EquivalentSatelecaccessdata.fda.gov
June 19, 2003K030916UFI GEL HARD CEBISubstantially EquivalentVoco GmbHaccessdata.fda.gov
June 13, 2003K030844FINAL VARNISH LCKLESubstantially EquivalentVoco GmbHaccessdata.fda.gov
July 18, 2001K011756ADMIRA FLOWEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
November 15, 2000K003153SOLOBOND PLUSKLESubstantially EquivalentVoco GmbHaccessdata.fda.gov
January 12, 2000K994056ADMIRAEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
February 10, 1998K974772UFI GEL CEBISubstantially EquivalentVoco GmbHaccessdata.fda.gov
March 31, 1993K926419CALCICUREJKSubstantially EquivalentVoco GmbHaccessdata.fda.gov
March 31, 1993K926418CLIPEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
October 16, 1992K924182CALCIMOL LCEJKSubstantially EquivalentVoco GmbHaccessdata.fda.gov
September 28, 1992K923849CALCIMOLEJKSubstantially EquivalentVoco GmbHaccessdata.fda.gov
March 19, 1992K920365TOOTH BONDING AGENTEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
February 25, 1992K915619IONOFIL/LONOFIL MOLAREMASubstantially EquivalentVoco GmbHaccessdata.fda.gov
February 25, 1992K915618PROVICOLEMASubstantially EquivalentVoco GmbHaccessdata.fda.gov
February 3, 1992K914612MERON DENTAL CEMENTEMASubstantially EquivalentVoco GmbHaccessdata.fda.gov
July 30, 1991K912495IONOSEALEJKSubstantially EquivalentVoco GmbHaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
January 25, 202493877Class IIOngoingIonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cementDue to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.accessdata.fda.gov
July 9, 201983385Class IITerminatedGrandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped deThe metal cannula are potentially too loose and may become loose when applying the filing material.accessdata.fda.gov
November 3, 201675782Class IITerminatedVOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use with methacrylate-based restorative, core build-up or luting materials. It can be applied with phosphoric acid eLabeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.accessdata.fda.gov

Compare with other makers

Updated May 1, 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.