Voco GmbH

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
116
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1142-2024Class IIIonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549;January 25, 2024
Z-1143-2024Class IIIonolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cementJanuary 25, 2024
Z-0028-2020Class IIGrandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all claJuly 9, 2019
Z-0955-2017Class IIVOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive November 3, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K251390MTA vptJuly 3, 2025
K251239GrandioSO UnlimitedMay 21, 2025
K231817AlignerFlow LCDecember 1, 2023
K231591V-Print c&b tempJuly 31, 2023
K230877Admira Fusion 5July 13, 2023
K220236V-Print dentbaseSeptember 21, 2022
K220640Bifix Hybrid Abutment CementAugust 23, 2022
K220743CediTECJuly 5, 2022
K213149VOCO Retraction PasteDecember 9, 2021
K201091V-Print splintNovember 6, 2020
K201090Structur CADSeptember 9, 2020
K201856Provicol QM AestheticAugust 26, 2020
K201307VisCalorJuly 8, 2020
K200294GrandioSO Light FlowMarch 27, 2020
K190453VisCalor bulkApril 11, 2019
K183147BrackFixMarch 1, 2019
K181312GrandioSO x-traAugust 22, 2018
K180386Meron Plus QMMay 8, 2018
K171815Registrado ScanNovember 15, 2017
K171200Grandio blocsAugust 10, 2017