25 results
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29ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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VOCO GmbH
Manufacturer
🇩🇪 Germany·3 Basic UDI-DIs·12 Devices
VOCO GMBH
FDA registration
VOCO GMBH·41 products·🇩🇪 Germany
Vococid Syringe
Device
EU MDR
·
Eu Md Class 1
·VOCO GmbH·On the market·32 countries
Vococid
Device
EU MDR
·
Eu Md Class 2a
·VOCO GmbH·On the market·32 countries
Vococid
Device
EU MDR
·
Eu Md Class 2a
·VOCO GmbH·On the market·32 countries
Vococid
Device
EU MDR
·
Eu Md Class 2a
·VOCO GmbH·On the market·32 countries
Vococid
Device
EU MDR
·
Eu Md Class 2a
·VOCO GmbH·On the market·32 countries
Vococid
Device
EU MDR
·
Eu Md Class 2a
·VOCO GmbH·On the market·32 countries
Vococid
Device
EU MDR
·
Eu Md Class 2a
·VOCO GmbH·On the market·32 countries
Vococid
Device
EU MDR
·
Eu Md Class 2a
·VOCO GmbH·On the market·32 countries
Futurabond U
Device
EU MDR
·
Eu Md Class 2a
·VOCO GmbH·On the market·32 countries
Futurabond U
Device
EU MDR
·
Eu Md Class 2a
·VOCO GmbH·On the market·32 countries
Futurabond U
Device
EU MDR
·
Eu Md Class 2a
·VOCO GmbH·On the market·32 countries
Futurabond U
Device
EU MDR
·
Eu Md Class 2a
·VOCO GmbH·On the market·32 countries
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 with phosphoric acid etching (selective enamel etching or total-etch) of the dental hard tissue as well as without (self-etch). A1] Adhesive for direct restorations of all classes of cavities using light-curing composite /compomer / Ormocer materials with a methacrylate base. [A2] Adhesive for core build-ups made of light-curing composite materials. [A3] Adhesive for indirect restorations with light-curing luting composites. [B] Intraoral repair of composite, compomer or Ormocer restorations, ceramic veneers and allceramic restorations without an additional primer. [C] Treatment of hypersensitive tooth necks. [D] Protective varnish for glass ionomer cement restorations. [E1] Sealing of cavities prior to amalgam restorations. [E2] Sealing of cavities and core preparations prior to the temporary luting of indirect restorations. In combination with Futurabond M+ DCA (Dual Cure Activator): [F1] Adhesive for direct self-curing or dual-curing composite restorations of all classes of cavities and for core build-ups.
FDA Enforcement
Class II
·Terminated·Voco GmbH·January 18, 2017
Vococid syringe
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·VOCO GmbH·1 device
Vococid
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·VOCO GmbH·7 devices
Futurabond U
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·VOCO GmbH·4 devices
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.).
FDA Enforcement
Class II
·Terminated·Voco GmbH·October 9, 2019
IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
FDA Enforcement
Class II
·Ongoing·Voco GmbH·February 28, 2024