Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010908

FEI Number

3002718942

Entity Name

VOCO GMBH

City/State/Country

CUXHAVEN Lower Saxony, DE

Establishment Address

ANTON-FLETTNER-STRASSE 1-3, CUXHAVEN Lower Saxony D-27472, DE

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

VOCO GMBH (Owner Number: 8010908)

Owner / Operator Contact Address

ANTON-FLETTNER-STRASSE 1-3, --, CUXHAVEN, DE-NOTA D-27472, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Registrado Scan Meron Plus AC Meron Plus V-Print dentbase VisCalor Ufi Gel SC Ufi Gel C Admira Fusion x-base V-Print ortho x-tra fil x-tra fil Caps Futurabond NR VOCO Retraction Paste Structur 2 QM Structur Premium Structur 3 Structur 2 SC VisCalor Bulk Grandio Seal VisCalor Dispenser Futurabond U Twinky Star Twinky Star NF Dimanto Meron Application Capsules Grandio SO Heavy Flow Structur CAD Bifix Veneer LC, Bifix Veneer Try-In Rebilda Post Rebilda Post GT Futurabond M SingleDose Futurabond M Calcimol V-Print c&b temp CediTEC DB VOCO Profluorid L IonoStar Plus Futurabond NR Single Dose Grandio SO Flow Provicol QM Plus x-tra base GrandioSO Light Flow Futurabond DC Single Dose Futurabond DC GrandioSO 4U Registrado X-tra mixing tips AlignerFlow LC VOCO Profluorid Varnish MTA vpt Grandio Core Dual Cure Rebilda DC Grandio Flow Ionolux V-Print ortho V-Print SG Curvy Admira Admira Caps Admira Bond Calcimol LC Ionoseal Reamer Rebilda Form Futurabond M+ VOCO Paste Remin Pro Admira Fusion 5 Bifix Temp Amaris Amaris Flow Bifix QM Admira Flow V-Print ortho V-Print SG GrandTEC VOCO Ionofil Molar AC Quick N-hybride composite LC Flow IonoStar Molar Fit Test C&B Provicol Provicol C Provicol QM Grandio blocs Grandio disc Structur 3 V-Print ortho Admira Fusion BrackFix V-Posil Heavy Soft Fast V-Posil Putty Fast V-Posil X-Light Fast V-Posil Light Fast V-Posil Mono Fast V-Posil Putty Soft Fast Solobond Plus Individo Lux Profibase V-Posil Adhesive V-Print Tray Modellsilikon MULTIPLE DEVICES Caps Warmer CediTEC Tooth Bonding Agent Vococid Grandio Flow Ufi Gel hard C VisCalor Barrier Sleeves GrandioSO x-tra CediTEC DT V-Print DT Calcicur TRAYPUROL TABS-IMPRESSION TRAY TRAY CLEANER Admira Fusion Flow Ionolux Pro Ionolux Final Varnish LC Clean Joy Meron V-Print Try-In Grandio disc multicolor Rebilda Post Drill

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2017-11-16
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-10-15
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2022-09-26
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-07-20
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2007-10-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2017-06-29
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2019-04-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-10-15
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-10-15
MVL	Cord, Retraction	Unknown	Class U	N/A	2021-12-10
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2007-10-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2019-04-15
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2007-10-15
QGO	Composite Resin Warmer	Dental	Class 1	872.6100	2021-01-06
EMA	Cement, Dental	Dental	Class 2	872.3275	2013-06-24
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2013-06-24
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-23
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2010-07-21
EMA	Cement, Dental	Dental	Class 2	872.3275	2013-10-24
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2010-11-16
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2020-09-09
EMA	Cement, Dental	Dental	Class 2	872.3275	2026-03-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2026-03-23
ELR	Post, Root Canal	Dental	Class 1	872.3810	2007-11-19
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2012-09-05
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2012-09-05
POW	Crown And Bridge, Long-Term Temporary, Resin	Dental	Class 2	872.3770	2023-08-01
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2023-08-01
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2023-09-08
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2023-09-08
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2009-09-09
EMA	Cement, Dental	Dental	Class 2	872.3275	2016-08-04
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-10-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-02-21
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2016-09-27
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-10-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-03-30
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-10-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-05-27
ELW	Material, Impression	Dental	Class 2	872.3660	2007-10-15
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2017-02-24
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2023-12-04
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2008-07-29
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2025-07-04
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-11-21
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-10-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2026-01-13
EMA	Cement, Dental	Dental	Class 2	872.3275	2012-09-05
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2010-06-22
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-10-15
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2012-09-05
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2007-10-15
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2010-01-08
EHQ	Cusp, Preformed	Dental	Class 1	872.3360	2011-03-18
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2014-08-25
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2010-10-26
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2023-07-14
EMA	Cement, Dental	Dental	Class 2	872.3275	2015-05-04
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-10-15
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-10-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-10-15
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2017-03-07
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2010-11-10
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-10-15
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2012-09-05
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-09-05
EMA	Cement, Dental	Dental	Class 2	872.3275	2014-10-21
ELW	Material, Impression	Dental	Class 2	872.3660	2011-04-01
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-10-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2017-08-14
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2015-10-29
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2019-04-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2015-07-03
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2019-03-01
ELW	Material, Impression	Dental	Class 2	872.3660	2017-02-24
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-10-15
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	1999-11-01
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2017-12-19
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2017-12-19
EFC	Warmer, Anesthetic Tube	Dental	Class 1	872.6100	2017-12-19
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2022-07-06
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-10-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-10-15
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2015-01-08
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2021-02-01
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2018-08-23
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2021-10-19
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2012-09-05
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2007-03-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2016-07-01
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2010-12-08
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-10-15
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2013-01-16
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-10-15
EEA	Plate, Base, Shellac	Dental	Class 1	872.6200	1999-11-01
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2026-04-29
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2007-11-30

Official Correspondent

No official correspondent registered.

US Agent Details

Leif Ebert Business: VOCO America Email: l.ebert@voco.com Phone: (888) 6582584

Related Public Records

Same Entity

VOCO GMBH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	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 including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010908. Last updated year: 2026. Please use registration number 8010908 when referencing this establishment in official correspondence.