Ivoclar Vivadent AG

• Ivocryl X 8 A-D IUK30 A3 Ref 631006

  Class IIa EUDAMED Active

• IPS e.max Ceram Art Illus & Structu Asso Ref 767451IN

  Class IIa EUDAMED Active

• Ivostar 6er A-D China O32 B2 Ref 582527

  Class IIa EUDAMED Active

• Ivostar Juego de 6 A-D China S33 C4 Ref 582551

  Class IIa EUDAMED Active

• Ivostar Set of 6 U44 01 Ref 541118

  Class IIa EUDAMED Active

• Ivostar Set of 6 A-D China L12 A3.5 Ref 582704

  Class IIa EUDAMED Active

• Ivocryl Juego de 6 A-D SOK26 BL2 Ref 630681

  Class IIa EUDAMED Active

• Gnathostar Juego de 8 A-D China ID88 BL2 Ref 605099

  Class IIa EUDAMED Active

• Ivocryl Set of 6 A-D UOK22 B3 Ref 630651

  Class IIa EUDAMED Active

• SR Nexco Paste Starter Kit A-D Ref 640399SN

  Class IIa EUDAMED Active

• IPS e.max Ceram Intro Assortment A3 Ref 762716DN

  Class IIa EUDAMED Active

• Ivotion BL3/Pref 98.5L/1 Ref 745747

  Class IIa EUDAMED Active

• Ivostar Set of 6 A-D China U03 C4 Ref 582461

  Class IIa EUDAMED Active

• ProArt CAD Try-in 98.5-30mm/1 Ref 686180

  Class I EUDAMED Active

• Ivocryl Set of 6 A-D UOK23 A2 Ref 633805

  Class IIa EUDAMED Active

• Ivocryl Set of 8 A-D UOK28 B1 Ref 630929

  Class IIa EUDAMED Active

• Gnathostar 8er A-D China OD84 A1 Ref 582262

  Class IIa EUDAMED Active

• Gnathostar Set of 8 A-D China UD82 BL3 Ref 612896

  Class IIa EUDAMED Active

• Ivocryl 8er A-D UUK28 B2 Ref 630990

  Class IIa EUDAMED Active

• Gnathostar 8er OD88 4D Ref 517110

  Class IIa EUDAMED Active

• Ivotion A3.5/Pref 98.5L/1 Ref 745748

  Class IIa EUDAMED Active

• Ivostar Set of 6 A-D China U01 A1 Ref 582413

  Class IIa EUDAMED Active

• Ivostar 6er A-D China O45 D4 Ref 582680

  Class IIa EUDAMED Active

• Ivostar Juego de 6 A-D China S02 B2 Ref 582437

  Class IIa EUDAMED Active

• Gnathostar Set of 8 UD88 1A Ref 517096

  Class IIa EUDAMED Active

• Gnathostar Bouche à 8 A-D China ID84 A1 Ref 582353

  Class IIa EUDAMED Active

• Ivostar Set of 6 A-D China U31 B2 Ref 582509

  Class IIa EUDAMED Active

• Variolink N-Esth LC Ref. 2g light Ref 770569AN

  Class IIa EUDAMED Active

• Ivostar Bouche à 6 A-D China S41 C2 Ref 582603

  Class IIa EUDAMED Active

• Ivostar Set of 6 A-D China U01 BL2 Ref 605028

  Class IIa EUDAMED Active

• Ivocryl Juego de 8 A-D SOK30 BL1 Ref 630940

  Class IIa EUDAMED Active

• Gnathostar Set of 8 UD86 1C Ref 517078

  Class IIa EUDAMED Active

• Gnathostar x 8 A-D China SD84 A4 Ref 582266

  Class IIa EUDAMED Active

• Ivostar Set of 6 A-D China U01 BL4 Ref 605049

  Class IIa EUDAMED Active

• Gnathostar Juego de 8 A-D China ID88 B2 Ref 582395

  Class IIa EUDAMED Active

• SR Triplex Cold Monomer 0, 5 l Ref 541445

  Class IIa EUDAMED Active

• Gnathostar Juego de 8 A-D China SD82 B2 Ref 582250

  Class IIa EUDAMED Active

• IPS Ivocolor Shade Kit Ref 667651PN

  Class IIa EUDAMED Active

• IPS Ivocolor Starter Kit Ref 667649AL

  Class IIa EUDAMED Active

• Gnathostar Juego de 8 A-D China SD88 A3 Ref 582300

  Class IIa EUDAMED Active

• IPS e.max Press MT A2 5 Stk. Ref 668757CN

  Class IIb EUDAMED Active

• Ivocryl X 6 A-D SOK34 B2 Ref 630750

  Class IIa EUDAMED Active

• Gnathostar Set of 8 LD84 4A Ref 517164

  Class IIa EUDAMED Active

• IPS e.max Ceram Selection Kit Ref 684732IN

  Class IIa EUDAMED Active

• Variolink N-Esth Try Ref. 1.7g neutral Ref 770582AN

  Class IIa EUDAMED Active

• Ivostar 6er A-D China O42 BL3 Ref 612855

  Class IIa EUDAMED Active

• Ivocryl Set of 8 A-D LUK32 B3 Ref 631031

  Class IIa EUDAMED Active

• Gnathostar Bouche à 8 ID80 2C Ref 517121

  Class IIa EUDAMED Active

• Ivostar Juego de 6 A-D China S41 BL3 Ref 612854

  Class IIa EUDAMED Active

• Ivostar Juego de 6 A-D China S41 D3 Ref 582607

  Class IIa EUDAMED Active

Showing the 10 most recent of 34 recalls.

• 2023

  • 21 Dec 2023 Z-1006-2024 Class II Ongoing Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected.via FDA establishment IVOCLAR VIVADENT, INC.

• 2017

  • 3 Aug 2017 Z-0665-2018 Class III Terminated Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.via FDA establishment IVOCLAR VIVADENT, INC.
  • 3 Aug 2017 Z-0666-2018 Class III Terminated Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.via FDA establishment IVOCLAR VIVADENT, INC.
  • 3 Aug 2017 Z-0667-2018 Class III Terminated Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.via FDA establishment IVOCLAR VIVADENT, INC.
  • 3 Aug 2017 Z-0668-2018 Class III Terminated Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.via FDA establishment IVOCLAR VIVADENT, INC.

• 2016

  • 9 Nov 2016 Z-0717-2017 Class II Terminated The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.via FDA establishment IVOCLAR VIVADENT, INC.
  • 9 Nov 2016 Z-0718-2017 Class II Terminated The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.via FDA establishment IVOCLAR VIVADENT, INC.
  • 9 Nov 2016 Z-0719-2017 Class II Terminated The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.via FDA establishment IVOCLAR VIVADENT, INC.
  • 11 Jul 2016 Z-2373-2016 Class II Terminated After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. OptraPol Small Flame is also affected. Two complaints were filed referring to OptraPol, claiming that the abrasive polishers wear faster than expected.via FDA establishment IVOCLAR VIVADENT, INC.
  • 27 May 2016 Z-0017-2017 Class II Terminated The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.via FDA establishment IVOCLAR VIVADENT, INC.

• Ivoclar Vivadent, Inc. Mississauga Ontario · CA FEI 3009496224
• Ivoclar Vivadent, Inc. Lipa City Batangas · PH FEI 3004362235
• Ivoclar Vivadent GmbH Ellwangen Baden-Wurttemberg · DE FEI 3004966444

Country

Liechtenstein

Address

2, Bendererstrasse, Schaan, Liechtenstein

Website

www.ivoclar.com

LinkedIn

linkedin.com/company/ivoclar-emea

Facebook

facebook.com/Ivoclar.de

Email

[email protected]

PRRC contact

Sandro Sbicego

EUDAMED SRN

LI-MF-000000522

FDA FEI number

3002808636