FDA Registration
Active
🇩🇪 Germany
VOCO GMBH
Reg #: 8010908
·
FEI: 3002718942
·
Expires 2026
Products
41
Proprietary Names
163
Establishment Types
5
Classifications
41
Registration Details
- Registration Name
- VOCO GMBH
- Registration Number
- 8010908
- FEI Number
- 3002718942
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ANTON-FLETTNER-STRASSE 1-3
- City
- CUXHAVEN Lower Saxony
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K171815
Owner / Operator
- Firm Name
- VOCO GMBH
- Operator Number
- 8010908
- Address
- ANTON-FLETTNER-STRASSE 1-3, --
- City
- CUXHAVEN
- State
- DE-NOTA
- Postal Code
- D-27472
- Country
- DE
US Agent
- Business Name
- VOCO America
- Contact Name
- Leif Ebert
- Address
- 1285 Rosemont Drive
- City
- Indian Land
- State
- SC
- ZIP
- 29707
- Country
- US
- [email protected]
- Phone
- 888 6582584
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2017-11-16 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2007-10-15 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2022-09-26 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2019-04-23 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2007-10-15 |
| Cord, Retraction | MVL | Class U | Unknown | No | 2021-12-10 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2007-10-15 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2007-10-15 |
| Composite Resin Warmer | QGO | Class 1 | Dental | No | 2021-01-06 |
| Disk, Abrasive | EHJ | Class 1 | Dental | No | 2010-07-21 |
| Post, Root Canal | ELR | Class 1 | Dental | No | 2007-11-19 |
| Liner, Cavity, Calcium Hydroxide | EJK | Class 2 | Dental | No | 2012-09-05 |
| Crown And Bridge, Long-Term Temporary, Resin | POW | Class 2 | Dental | No | 2023-08-01 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2023-09-08 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2009-09-09 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2016-09-27 |
| Material, Impression | ELW | Class 2 | Dental | No | 2007-10-15 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2017-02-24 |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | Class 2 | Dental | No | 2023-12-04 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2025-07-04 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2010-06-22 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2010-01-08 |
| Cusp, Preformed | EHQ | Class 1 | Dental | No | 2011-03-18 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2010-10-26 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2017-03-07 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2019-04-23 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 1999-11-01 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2017-12-19 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2017-12-19 |
| Warmer, Anesthetic Tube | EFC | Class 1 | Dental | No | 2017-12-19 |
| Dental Barriers And Sleeves | PEM | Class 2 | General, Plastic Surgery | No | 2021-02-01 |
| Denture, Plastic, Teeth | ELM | Class 2 | Dental | No | 2021-10-19 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2007-03-15 |
| Plate, Base, Shellac | EEA | Class 1 | Dental | No | 1999-11-01 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2007-11-30 |
| Amalgamator, Dental, Ac-Powered | EFD | Class 1 | Dental | No | 2017-04-26 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 1994-10-07 |
| Coating, Filling Material, Resin | EBD | Class 2 | Dental | No | 2008-11-27 |
| Point, Abrasive | EHL | Class 1 | Dental | No | 2005-12-19 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2010-01-08 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2011-03-18 |
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 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
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
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
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
Final Varnish LC
Clean Joy
Meron
V-Print Try-In
Grandio disc multicolor
Rebilda Post Drill
VOCO GIC Mixer II
VOCO Dynamic Dispenser
VOCO GIC Mixer
Micro Tim
Single Tim
Endo Tim
PELE TIM
Sticky Tim
Provicol QM Aesthetic
Clip Caps
Clip
Control Seal
Amaris Gingiva
Celalux 3
Easy Glaze
SiC Grinding Bur
Trimming Disk
Grandio Caps
Grandio
Celalux II
Bifix SE
Bifix Hybrid Abutment Cement
Ceramic Bond
Quick Up
Grandio SO
Admira Fusion x-tra
V-Print splint
Temporary C&B Composite
Admira Protect Single Dose
Admira Protect
Dispenser
AC Activator
application cannulae
mixing pad
mixing pallets
Trifill instrument
Intra oral tips
AC Applicator
Brush holder
Caps Dispenser
disposable brushes
Easy Brush
Clip Flow
Meron Plus QM
N-hybride composite LC
VOCO Profluorid Varnish + BioMin
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Foreign Private Label Distributor