Voco GmbH
Voco GmbH holds FDA 510(k) medical device clearances, first cleared 1991, most recent 2026, with 4 FDA device recalls on record.
Top product codes for Voco GmbH
FDA recalls by Voco GmbH
- Z-1142-2024 — IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
- Z-1143-2024 — Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
- Z-0028-2020 — 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-0955-2017 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Voco GmbH
1–100 of 119- K252073 — VOCO Profluorid Varnish + BioMin
- K261357 — Grandio disc multicolor
- K252606 — Bifix Veneer LC, Bifix Veneer Try-In
- K251390 — MTA vpt
- K251239 — GrandioSO Unlimited
- K231817 — AlignerFlow LC
- K231591 — V-Print c&b temp
- K230877 — Admira Fusion 5
- K220236 — V-Print dentbase
- K220640 — Bifix Hybrid Abutment Cement
- K220743 — CediTEC
- K213149 — VOCO Retraction Paste
- K201091 — V-Print splint
- K201090 — Structur CAD
- K201856 — Provicol QM Aesthetic
- K201307 — VisCalor
- K200294 — GrandioSO Light Flow
- K190453 — VisCalor bulk
- K183147 — BrackFix
- K181312 — GrandioSO x-tra
- K180386 — Meron Plus QM
- K171815 — Registrado Scan
- K171200 — Grandio blocs
- K170896 — Admira Fusion x-base
- K161630 — Provicol QM Plus
- K160774 — IonoStar Plus
- K153493 — Clip Flow
- K153177 — Admira Fusion Flow
- K153018 — CELALUX 3
- K151956 — Admira Fusion x-tra
- K150784 — Admira Fusion
- K143212 — Bifix Temp
- K143486 — Ufi Gel hard C
- K140993 — IONOSTAR MOLAR
- K141610 — FUTURABOND M+
- K130485 — CONTROL SEAL
- K130421 — MERON APPLICATION CAPSULES
- K130486 — FUTURABOND UNIVERSAL
- K123773 — X-TRA BASE
- K120779 — STRUCTUR 3
- K113444 — N-HYBRIDE-COMPOSITE LC FLOW
- K113563 — N-HYBRIDE-COMPOSITE LC
- K112447 — GRANDIO CORE DUAL CURE
- K112374 — X-TRA BASE
- K110589 — CIMARA
- K110440 — QUICK UP
- K110050 — FIT TEST C&B
- K103580 — GRANDIO SO FLOW
- K102612 — VOCO IONOFIL MOLAR AC QUICK
- K102354 — GRANDIO SO HEAVY FLOW
- K102351 — GRANDIO SO
- K102347 — GRANDTEC
- K101104 — REMIN PRO
- K102450 — IONOLUX PRO
- K101213 — GRANDIO FLOW
- K090817 — IONOLUX
- K091894 — TEMPORARY C&B COMPOSITE
- K090843 — AMARIS GINGIVA OPAQUER
- K083438 — BIFIX SE
- K083036 — VOCO PROFLUORID L
- K082753 — FUTURABOND M/FUTURABOND M SINGLE DOSE
- K082285 — EASY GLAZE
- K080814 — VOCO PROFLUORID VARNISH
- K070723 — FUTURABOND DC/SINGLE DOSE
- K071386 — AMARIS/AMARIS FLOW
- K063604 — TWINKY STAR NF
- K063554 — MERON PLUS
- K062345 — CERAMIC BOND
- K062343 — GRANDIO FLOW TRY-IN
- K062344 — GRANDIO SEAL
- K061823 — ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE
- K060893 — MODIFICATION TO REBILDA DC
- K060894 — BIFIX QM
- K053391 — X-TRA FIL
- K053392 — FUTURABOND NR SINGLE DOSE
- K051867 — GRANDIO
- K051868 — GRANDIO FLOW
- K051535 — MODIFICATION TO:REGISTRADO X-TRA
- K042670 — FUTURABOND NR
- K042669 — IONOFIL PLUS AC
- K040769 — STRUCTUR 2 SC
- K033117 — GRANDIO FLOW
- K033068 — IONOFIL COLOR AC
- K030916 — UFI GEL HARD C
- K030844 — FINAL VARNISH LC
- K030914 — REBILDA DC
- K030915 — GRANDIO
- K022797 — TWINKY STAR
- K022066 — REGISTRADO X-TRA
- K021842 — ADMIRA SEAL
- K021844 — ADMIRA PROTECT
- K014111 — REBILDA SC
- K011756 — ADMIRA FLOW
- K003153 — SOLOBOND PLUS
- K994304 — ARABESK FLOW
- K994268 — ARABESK TOP
- K993827 — UFI GEL HARD
- K994056 — ADMIRA
- K980539 — SOLOBOND M
- K974772 — UFI GEL C
Data sourced from openFDA. This site is unofficial and independent of the FDA.