ClearanceBrief
Company ยท DE

Voco GmbH

FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2026. Name variants (Inc, Corp, punctuation) are merged.

119510(k) clearances (3 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)

Product codes

CodeDeviceRecords
EBFMaterial, Tooth Shade, Resin46
EMACement, Dental28
KLEAgent, Tooth Bonding, Resin11
EBIResin, Denture, Relining, Repairing, Rebasing8
EBCSealant, Pit And Fissure, And Conditioner5
EBGCrown And Bridge, Temporary, Resin5
EJKLiner, Cavity, Calcium Hydroxide4
ELWMaterial, Impression3
LBHVarnish, Cavity3
DYHAdhesive, Bracket And Tooth Conditioner, Resin2
EBDCoating, Filling Material, Resin1
EBZActivator, Ultraviolet, For Polymerization1
EJRAgent, Polishing, Abrasive, Oral Cavity1
EMBZinc Oxide Eugenol1
KIFResin, Root Canal Filling1
MQCMouthguard, Prescription1
MVLCord, Retraction1
POWCrown And Bridge, Long-Term Temporary, Resin1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 1, 2026K252073VOCO Profluorid Varnish + BioMin
Voco GmbH, DE
LBH
Apr 27, 2026K261357Grandio disc multicolor
Voco GmbH, DE
EBF
Mar 20, 2026K252606Bifix Veneer LC, Bifix Veneer Try-In
Voco GmbH, DE
EMA
Jul 3, 2025K251390MTA vpt
Voco GmbH, DE
KIF
May 21, 2025K251239GrandioSO Unlimited
Voco GmbH, DE
EBF
Dec 1, 2023K231817AlignerFlow LC
Voco GmbH, DE
DYH
Jul 31, 2023K231591V-Print c&b temp
Voco GmbH, DE
POW
Jul 13, 2023K230877Admira Fusion 5
Voco GmbH, DE
EBF
Sep 21, 2022K220236V-Print dentbase
Voco GmbH, DE
EBI
Aug 23, 2022K220640Bifix Hybrid Abutment Cement
Voco GmbH, DE
EMA
Jul 5, 2022K220743CediTEC
Voco GmbH, DE
EBI
Dec 9, 2021K213149VOCO Retraction Paste
Voco GmbH, DE
MVL
Nov 6, 2020K201091V-Print splint
Voco GmbH, DE
MQC
Sep 9, 2020K201090Structur CAD
Voco GmbH, DE
EBG
Aug 26, 2020K201856Provicol QM Aesthetic
Voco GmbH, DE
EMA
Jul 8, 2020K201307VisCalor
Voco GmbH, DE
EBF
Mar 27, 2020K200294GrandioSO Light Flow
Voco GmbH, DE
EBF
Apr 11, 2019K190453VisCalor bulk
Voco GmbH, DE
EBF
Mar 1, 2019K183147BrackFix
Voco GmbH, DE
DYH
Aug 22, 2018K181312GrandioSO x-tra
Voco GmbH, DE
EBF
May 8, 2018K180386Meron Plus QM
Voco GmbH, DE
EMA
Nov 15, 2017K171815Registrado Scan
Voco GmbH, DE
EBF
Aug 10, 2017K171200Grandio blocs
Voco GmbH, DE
EBF
Jun 29, 2017K170896Admira Fusion x-base
Voco GmbH, DE
EBF
Sep 15, 2016K161630Provicol QM Plus
Voco GmbH, DE
EMB
Aug 3, 2016K160774IonoStar Plus
Voco GmbH, DE
EMA
Jul 29, 2016K153493Clip Flow
Voco GmbH, DE
EBF
Jun 30, 2016K153177Admira Fusion Flow
Voco GmbH, DE
EBF
Jun 23, 2016K153018CELALUX 3
Voco GmbH, DE
EBZ
Oct 20, 2015K151956Admira Fusion x-tra
Voco GmbH, DE
EBF
Jul 2, 2015K150784Admira Fusion
Voco GmbH, DE
EBF
May 1, 2015K143212Bifix Temp
Voco GmbH, DE
EMA
Jan 7, 2015K143486Ufi Gel hard C
Voco GmbH, DE
EBI
Oct 20, 2014K140993IONOSTAR MOLAR
Voco GmbH, DE
EMA
Aug 1, 2014K141610FUTURABOND M+
Voco GmbH, DE
KLE
Feb 11, 2014K130485CONTROL SEAL
Voco GmbH, DE
EBC
Aug 14, 2013K130421MERON APPLICATION CAPSULES
Voco GmbH, DE
EMA
Jun 20, 2013K130486FUTURABOND UNIVERSAL
Voco GmbH, DE
KLE
Dec 21, 2012K123773X-TRA BASE
Voco GmbH, DE
EBF
Jun 1, 2012K120779STRUCTUR 3
Voco GmbH, DE
EBG
Dec 21, 2011K113563N-HYBRIDE-COMPOSITE LC
Voco GmbH, DE
EBF
Dec 21, 2011K113444N-HYBRIDE-COMPOSITE LC FLOW
Voco GmbH, DE
EBF
Nov 8, 2011K112447GRANDIO CORE DUAL CURE
Voco GmbH, DE
EBF
Oct 20, 2011K112374X-TRA BASE
Voco GmbH, DE
EBF
May 27, 2011K110589CIMARA
Voco GmbH, DE
EBF
May 4, 2011K110440QUICK UP
Voco GmbH, DE
EBI
Mar 28, 2011K110050FIT TEST C&B
Voco GmbH, DE
ELW
Jan 21, 2011K103580GRANDIO SO FLOW
Voco GmbH, DE
EBF
Nov 19, 2010K102612VOCO IONOFIL MOLAR AC QUICK
Voco GmbH, DE
EMA
Nov 8, 2010K102354GRANDIO SO HEAVY FLOW
Voco GmbH, DE
EBF

Newest 50 of 119.

Latest recalls

DateFirm and productCodeLinked 510(k)
Feb 16, 2024Voco GmbH
Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
Open, Classified		 EMAK090817
Feb 16, 2024Voco GmbH
IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
Open, Classified		 EMAK160774
Oct 1, 2019Voco GmbH
Grandio 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 i
Terminated		 EBFK102354
Jan 6, 2017Voco GmbH
VOCO 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 wi
Terminated		 KLEK141610
Get alerts for these product codes