Manufacturer registered with FDA

Voco GmbH

CUXHAVEN, Germany. Lists 37 dental device types with FDA across 1 registered establishment, and holds 117 510(k) clearances as applicant.

FDA owner/operator8010908Foreign exporterManufacturerPrivate-label distributorRepacker / relabeler11 clearances in five years

Device types listed: 37
Brands and models: 170
510(k) clearances: 1171991–2026
Markets registered in: 7646 registrations outside the US
Establishments: 1Germany

510(k) clearances per year, 1990–2026

Registered in 7 markets

Where regulators' registries name Voco GmbH as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: GermanyOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Voco GmbH	117 clearances	1991–2026	Below
European Union	EUDAMED	Registration holder	VOCO GmbH	273	—	Pure Global AI
Colombia	INVIMA	Manufacturer	VOCO GMBHVOCO GMBH.	191	—	Pure Global AI
Brazil	ANVISA	Manufacturer	VOCO GMBH	90	2005–2026	Pure Global AI
Taiwan	TFDA	Manufacturer	VOCO GMBH	59	2006–2024	Pure Global AI
Peru	DIGEMID	Manufacturer	VOCO GmbHVOCO GMBH	29	2012–2026	Pure Global AI
Israel	AMAR	Manufacturer	VOCO GmbHVOCO	4	—	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Voco GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Resin Tooth Shade MaterialEBF · Class 2	Dental composites	Maker	AdmiraAdmira BondAdmira CapsAdmira FlowAdmira FusionAdmira Fusion 5Admira Fusion FlowAdmira Fusion x-baseAdmira Fusion x-traAmaris 35 more Amaris FlowAmaris GingivaBifix Veneer LC, Bifix Veneer Try-InCeramic BondClipClip CapsClip FlowGrandioGrandio blocsGrandio CapsGrandio Core Dual CureGrandio discGrandio disc multicolorGrandio FlowGrandio SOGrandio SO FlowGrandio SO Heavy FlowGrandioSO 4UGrandioSO Light FlowGrandioSO x-traIonoluxIonolux ProN-hybride composite LCN-hybride composite LC FlowRebilda DCRegistrado ScanTooth Bonding AgentTwinky StarTwinky Star NFVisCalorVisCalor BulkVococidx-tra basex-tra filx-tra fil Caps	2007
Dental CementEMA · Class 2	Dental cements	Maker	Bifix Hybrid Abutment CementBifix QMBifix SEBifix TempBifix Veneer LC, Bifix Veneer Try-InFuturabond UIonoluxIonoStar MolarIonoStar PlusMeron 9 more Meron Application CapsulesMeron PlusMeron Plus ACMeron Plus QMProvicolProvicol CProvicol QMProvicol QM AestheticVOCO Ionofil Molar AC Quick	2007
Rebasing Repairing Relining Denture ResinEBI · Class 2	Denture resins & teeth	Maker	CediTECCediTEC DBGrandTECQuick UpUfi Gel CUfi Gel hard CUfi Gel SCV-Print dentbase	2007
Resin Tooth Bonding AgentKLE · Class 2	Bonding agents	Maker	Final Varnish LCFuturabond DCFuturabond DC Single DoseFuturabond MFuturabond M SingleDoseFuturabond M+Futurabond NRFuturabond NR Single DoseFuturabond USolobond Plus	2007
Pit and Fissure Sealant and ConditionerEBC · Class 2	Sealants & varnishes	Maker	Admira ProtectAdmira Protect Single DoseControl SealGrandio SealN-hybride composite LCN-hybride composite LC Flow	2007
Resin Temporary Crown and BridgeEBG · Class 2	Temporary crown & bridge materials	Maker	Structur 2 QMStructur 2 SCStructur 3Structur CADStructur PremiumTemporary C&B CompositeV-Print c&b temp	2007
Ultraviolet Activator for PolymerizationEBZ · Class 2	Curing lights	Lister	Caps WarmerCelalux 3Celalux IITwinWave	2008
Calcium Hydroxide Cavity LinerEJK · Class 2	—	Maker	CalcicurCalcimolCalcimol LCIonoseal	2007
Impression MaterialELW · Class 2	Impression materials	Maker	Fit Test C&BRegistrado X-traV-Posil Heavy Soft FastV-Posil Light FastV-Posil Mono FastV-Posil Putty FastV-Posil Putty Soft FastV-Posil X-Light Fast	2007
Cavity VarnishLBH · Class 2	Sealants & varnishes	Maker	VOCO Profluorid LVOCO Profluorid VarnishVOCO Profluorid Varnish + BioMin	2008
Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2	—	Maker	AlignerFlow LCBrackFix	2019
Oral Cavity Abrasive Polishing AgentEJR · Class 1	Polishing & prophylaxis	Maker	Clean JoyRemin ProVOCO Paste	2010
Orthodontic Screw Expansion RetainerDYJ · Class 1	Retainers, expanders & headgear	Lister	V-Print ortho	2019
Orthodontic Space Preformed MaintainerDYT · Class 1	Retainers, expanders & headgear	Lister	V-Print ortho	2019
Intraoral Dental DrillDZA · Class 1	Surgical drills & motors	Lister	Rebilda Post Drill	2007
Dental Hand InstrumentsDZN · Class 1	Dental hand instruments	Lister	application cannulae	2011
Resin Filling Material CoatingEBD · Class 2	—	Maker	Easy Glaze	2008
Resin Impression Tray MaterialEBH · Class 1	Impression trays	Maker	Individo LuxModellsilikonMULTIPLE DEVICESProfibaseV-Posil AdhesiveV-Print Tray	1999
Shellac Base PlateEEA · Class 1	—	Maker	V-Print Try-In	1999
Heat Source for Bleaching TeethEEG · Class 1	Teeth whitening lights	Lister	Caps Warmer	2017
Anesthetic Tube WarmerEFC · Class 1	—	Lister	Caps Warmer	2017
Ac-Powered Dental AmalgamatorEFD · Class 1	—	Lister	VOCO Dynamic DispenserVOCO GIC MixerVOCO GIC Mixer II	2017
Abrasive DiskEHJ · Class 1	Polishing & prophylaxis	Maker	Dimanto	2010
Abrasive PointEHL · Class 1	Polishing & prophylaxis	Lister	SiC Grinding BurTrimming Disk	2005
Preformed CuspEHQ · Class 1	—	Maker	Rebilda Form	2011
Preformed Impression TrayEHY · Class 1	Impression trays	Maker	TRAY CLEANERTRAYPUROL TABS-IMPRESSION TRAY	2007
Restorative and Impression Material SyringeEID · Class 1	Dental hand instruments	Lister	mixing tips	2017
Dental Instrument HandleEJB · Class 1	Dental hand instruments	Lister	AC ActivatorAC Applicatorapplication cannulaeBrush holderCaps DispenserDispenserdisposable brushesEasy BrushIntra oral tipsmixing pad 3 more mixing palletsmixing tipsTrifill instrument	2010
Endodontic Pulp Canal FileEKS · Class 1	Endodontic files	Maker	Reamer	2010
Teeth Plastic DentureELM · Class 2	Denture resins & teeth	Maker	CediTEC DTV-Print DT	2021
Root Canal PostELR · Class 1	Root canal filling materials	Maker	Rebilda PostRebilda Post GT	2007
Zinc Oxide EugenolEMB · Class 1	Dental cements	Maker	Provicol QM Plus	2016
Root Canal Filling ResinKIF · Class 2	Root canal filling materials	Maker	MTA vpt	2025
Preformed Tooth PositionerKMY · Class 1	Retainers, expanders & headgear	Maker	CurvyV-Print orthoV-Print SG	2010
Endosseous Dental Implant AccessoriesNDP · Class 1	Implant instruments & surgical kits	Lister	V-Print orthoV-Print SG	2017
Resin Long-Term Temporary Crown and BridgePOW · Class 2	—	Maker	V-Print c&b temp	2023
Composite Resin WarmerQGO · Class 1	—	Lister	VisCalor Dispenser	2021

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Voco GmbH as the applicant.

Decided	510(k)	Device	Device type
1 May 2026	K252073	VOCO Profluorid Varnish + BioMin	LBH Cavity Varnish
27 Apr 2026	K261357	Grandio disc multicolor	EBF Resin Tooth Shade Material
20 Mar 2026	K252606	Bifix Veneer LC, Bifix Veneer Try-In	EMA Dental Cement
3 Jul 2025	K251390	MTA vpt	KIF Root Canal Filling Resin
21 May 2025	K251239	GrandioSO Unlimited	EBF Resin Tooth Shade Material
1 Dec 2023	K231817	AlignerFlow LC	DYH Resin Bracket and Tooth Conditioner Adhesive
31 Jul 2023	K231591	V-Print c&b temp	POW Resin Long-Term Temporary Crown and Bridge
13 Jul 2023	K230877	Admira Fusion 5	EBF Resin Tooth Shade Material
21 Sep 2022	K220236	V-Print dentbase	EBI Rebasing Repairing Relining Denture Resin
23 Aug 2022	K220640	Bifix Hybrid Abutment Cement	EMA Dental Cement
5 Jul 2022	K220743	CediTEC	EBI Rebasing Repairing Relining Denture Resin
9 Sep 2020	K201090	Structur CAD	EBG Resin Temporary Crown and Bridge
26 Aug 2020	K201856	Provicol QM Aesthetic	EMA Dental Cement
8 Jul 2020	K201307	VisCalor	EBF Resin Tooth Shade Material
27 Mar 2020	K200294	GrandioSO Light Flow	EBF Resin Tooth Shade Material
11 Apr 2019	K190453	VisCalor bulk	EBF Resin Tooth Shade Material
1 Mar 2019	K183147	BrackFix	DYH Resin Bracket and Tooth Conditioner Adhesive
22 Aug 2018	K181312	GrandioSO x-tra	EBF Resin Tooth Shade Material
8 May 2018	K180386	Meron Plus QM	EMA Dental Cement
15 Nov 2017	K171815	Registrado Scan	EBF Resin Tooth Shade Material
10 Aug 2017	K171200	Grandio blocs	EBF Resin Tooth Shade Material
29 Jun 2017	K170896	Admira Fusion x-base	EBF Resin Tooth Shade Material
15 Sep 2016	K161630	Provicol QM Plus	EMB Zinc Oxide Eugenol
3 Aug 2016	K160774	IonoStar Plus	EMA Dental Cement
29 Jul 2016	K153493	Clip Flow	EBF Resin Tooth Shade Material
30 Jun 2016	K153177	Admira Fusion Flow	EBF Resin Tooth Shade Material
23 Jun 2016	K153018	CELALUX 3	EBZ Ultraviolet Activator for Polymerization
20 Oct 2015	K151956	Admira Fusion x-tra	EBF Resin Tooth Shade Material
2 Jul 2015	K150784	Admira Fusion	EBF Resin Tooth Shade Material
1 May 2015	K143212	Bifix Temp	EMA Dental Cement
7 Jan 2015	K143486	Ufi Gel hard C	EBI Rebasing Repairing Relining Denture Resin
20 Oct 2014	K140993	IONOSTAR MOLAR	EMA Dental Cement
1 Aug 2014	K141610	FUTURABOND M+	KLE Resin Tooth Bonding Agent
11 Feb 2014	K130485	CONTROL SEAL	EBC Pit and Fissure Sealant and Conditioner
14 Aug 2013	K130421	MERON APPLICATION CAPSULES	EMA Dental Cement
20 Jun 2013	K130486	FUTURABOND UNIVERSAL	KLE Resin Tooth Bonding Agent
21 Dec 2012	K123773	X-TRA BASE	EBF Resin Tooth Shade Material
1 Jun 2012	K120779	STRUCTUR 3	EBG Resin Temporary Crown and Bridge
21 Dec 2011	K113563	N-HYBRIDE-COMPOSITE LC	EBF Resin Tooth Shade Material
21 Dec 2011	K113444	N-HYBRIDE-COMPOSITE LC FLOW	EBF Resin Tooth Shade Material
8 Nov 2011	K112447	GRANDIO CORE DUAL CURE	EBF Resin Tooth Shade Material
20 Oct 2011	K112374	X-TRA BASE	EBF Resin Tooth Shade Material
27 May 2011	K110589	CIMARA	EBF Resin Tooth Shade Material
4 May 2011	K110440	QUICK UP	EBI Rebasing Repairing Relining Denture Resin
28 Mar 2011	K110050	FIT TEST C&B	ELW Impression Material
21 Jan 2011	K103580	GRANDIO SO FLOW	EBF Resin Tooth Shade Material
19 Nov 2010	K102612	VOCO IONOFIL MOLAR AC QUICK	EMA Dental Cement
8 Nov 2010	K102354	GRANDIO SO HEAVY FLOW	EBF Resin Tooth Shade Material
2 Nov 2010	K102351	GRANDIO SO	EBF Resin Tooth Shade Material
29 Oct 2010	K102347	GRANDTEC	EBI Rebasing Repairing Relining Denture Resin
21 Oct 2010	K101104	REMIN PRO	EJR Oral Cavity Abrasive Polishing Agent
8 Oct 2010	K102450	IONOLUX PRO	EBF Resin Tooth Shade Material
19 Aug 2010	K101213	GRANDIO FLOW	EBF Resin Tooth Shade Material
23 Jul 2009	K091894	TEMPORARY C&B COMPOSITE	EBG Resin Temporary Crown and Bridge
23 Jul 2009	K090817	IONOLUX	EMA Dental Cement
17 Jun 2009	K090843	AMARIS GINGIVA OPAQUER	EBF Resin Tooth Shade Material
13 Feb 2009	K083438	BIFIX SE	EMA Dental Cement
12 Jan 2009	K083036	VOCO PROFLUORID L	LBH Cavity Varnish
24 Nov 2008	K082753	FUTURABOND M/FUTURABOND M SINGLE DOSE	KLE Resin Tooth Bonding Agent
24 Oct 2008	K082285	EASY GLAZE	EBD Resin Filling Material Coating
24 Jul 2008	K080814	VOCO PROFLUORID VARNISH	LBH Cavity Varnish
7 Jun 2007	K070723	FUTURABOND DC/SINGLE DOSE	KLE Resin Tooth Bonding Agent
5 Jun 2007	K071386	AMARIS/AMARIS FLOW	EBF Resin Tooth Shade Material
22 Jan 2007	K063604	TWINKY STAR NF	EBF Resin Tooth Shade Material
12 Jan 2007	K063554	MERON PLUS	EMA Dental Cement
15 Dec 2006	K062345	CERAMIC BOND	EBF Resin Tooth Shade Material
2 Nov 2006	K062343	GRANDIO FLOW TRY-IN	EBF Resin Tooth Shade Material
2 Oct 2006	K062344	GRANDIO SEAL	EBC Pit and Fissure Sealant and Conditioner
21 Jul 2006	K061823	ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE	EBC Pit and Fissure Sealant and Conditioner
25 May 2006	K060893	MODIFICATION TO REBILDA DC	EBF Resin Tooth Shade Material
2 May 2006	K060894	BIFIX QM	EMA Dental Cement
15 Feb 2006	K053391	X-TRA FIL	EBF Resin Tooth Shade Material
15 Dec 2005	K053392	FUTURABOND NR SINGLE DOSE	KLE Resin Tooth Bonding Agent
27 Jul 2005	K051868	GRANDIO FLOW	EBF Resin Tooth Shade Material
27 Jul 2005	K051867	GRANDIO	EBF Resin Tooth Shade Material
28 Jun 2005	K051535	MODIFICATION TO:REGISTRADO X-TRA	ELW Impression Material
1 Nov 2004	K042670	FUTURABOND NR	KLE Resin Tooth Bonding Agent
20 Oct 2004	K042669	IONOFIL PLUS AC	EMA Dental Cement
7 Apr 2004	K040769	STRUCTUR 2 SC	EBG Resin Temporary Crown and Bridge
25 Nov 2003	K033117	GRANDIO FLOW	EBF Resin Tooth Shade Material
31 Oct 2003	K033068	IONOFIL COLOR AC	EMA Dental Cement
19 Jun 2003	K030916	UFI GEL HARD C	EBI Rebasing Repairing Relining Denture Resin
13 Jun 2003	K030844	FINAL VARNISH LC	KLE Resin Tooth Bonding Agent
30 May 2003	K030915	GRANDIO	EBF Resin Tooth Shade Material
30 May 2003	K030914	REBILDA DC	EBF Resin Tooth Shade Material
10 Oct 2002	K022797	TWINKY STAR	EBF Resin Tooth Shade Material
14 Aug 2002	K022066	REGISTRADO X-TRA	ELW Impression Material
29 Jul 2002	K021842	ADMIRA SEAL	EBC Pit and Fissure Sealant and Conditioner
19 Jul 2002	K021844	ADMIRA PROTECT	EBC Pit and Fissure Sealant and Conditioner
6 Mar 2002	K014111	REBILDA SC	EBF Resin Tooth Shade Material
18 Jul 2001	K011756	ADMIRA FLOW	EBF Resin Tooth Shade Material
15 Nov 2000	K003153	SOLOBOND PLUS	KLE Resin Tooth Bonding Agent
7 Feb 2000	K994304	ARABESK FLOW	EBF Resin Tooth Shade Material
3 Feb 2000	K994268	ARABESK TOP	EBF Resin Tooth Shade Material
20 Jan 2000	K993827	UFI GEL HARD	EBI Rebasing Repairing Relining Denture Resin
12 Jan 2000	K994056	ADMIRA	EBF Resin Tooth Shade Material
23 Mar 1998	K980539	SOLOBOND M	KLE Resin Tooth Bonding Agent
10 Feb 1998	K974772	UFI GEL C	EBI Rebasing Repairing Relining Denture Resin
13 Apr 1994	K941124	STRUCTUR 2	EBG Resin Temporary Crown and Bridge
17 Jun 1993	K930116	LCL 8	EMA Dental Cement
8 Apr 1993	K930455	CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER	EMA Dental Cement
8 Apr 1993	K926492	ARGION DENTAL CEMENT	EMA Dental Cement
31 Mar 1993	K926458	BIFIX DENTAL CEMENT	EMA Dental Cement
31 Mar 1993	K926419	CALCICUR	EJK Calcium Hydroxide Cavity Liner
31 Mar 1993	K926418	CLIP	EBF Resin Tooth Shade Material
16 Oct 1992	K924182	CALCIMOL LC	EJK Calcium Hydroxide Cavity Liner
16 Oct 1992	K924181	POLIBOND	KLE Resin Tooth Bonding Agent
28 Sep 1992	K923849	CALCIMOL	EJK Calcium Hydroxide Cavity Liner
10 Aug 1992	K922853	AQUA IONOFIL	EMA Dental Cement
5 Aug 1992	K922854	AQUA MERON	EMA Dental Cement
19 Mar 1992	K920365	TOOTH BONDING AGENT	EBF Resin Tooth Shade Material
25 Feb 1992	K915619	IONOFIL/LONOFIL MOLAR	EMA Dental Cement
25 Feb 1992	K915618	PROVICOL	EMA Dental Cement
3 Feb 1992	K914612	MERON DENTAL CEMENT	EMA Dental Cement
21 Oct 1991	K914073	F21(R) DENTAL CEMENT	EMA Dental Cement
30 Jul 1991	K912497	IONOBOND	EMA Dental Cement
30 Jul 1991	K912495	IONOSEAL	EJK Calcium Hydroxide Cavity Liner

Some of these clearances are listed with FDA today by another company: Centrix, Inc. (5), Kettenbach GmbH & Co. KG (2), Den-Mat Holdings, LLC (2), Ivoclar Vivadent, AG (1), Young Innovations Inc (1).

Also lists devices cleared under other names

Voco GmbH lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Dental Direkt GmbH (1), Foshan COXO Medical Instrument Co., Ltd. (1), Kettenbach GmbH & Co. KG (1), Addent, Inc. (1), Satelec (1).

Decided	510(k)	Device	Applicant	Device type
23 Jun 2023	K230410	DD medical polymers (PMMA)	Dental Direkt GmbH	EBI Rebasing Repairing Relining Denture Resin
8 Dec 2022	K220826	LED Curing Light	Foshan COXO Medical Instrument Co., Ltd.	EBZ Ultraviolet Activator for Polymerization
8 Sep 2008	K082560	PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT	Kettenbach GmbH & Co. KG	ELW Impression Material
23 Jun 2006	K061395	CALSET COMPOSITE HEATER	Addent, Inc.	EBZ Ultraviolet Activator for Polymerization
21 Oct 2003	K032465	MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI	Satelec	EBZ Ultraviolet Activator for Polymerization

Registered establishments

Establishment	Location	What it does
VOCO GMBHFDA reg. 8010908	CUXHAVEN Lower Saxony, Germany	Foreign exporter, Manufacturer, Private-label distributor, Repacker / relabeler, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 8010908). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.