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Ivoclar Vivadent AG

Active in EUDAMED

Liechtensteinfrom SRN EUDAMED FDA SRN LI-MF-000000522 FEI 3002808636

Devices
5,758
Registrations
EUDAMEDFDA
FDA recalls
341 ongoing

What Ivoclar Vivadent AG makes

The company manufactures dental composite resins, including sets and individual shades for restorative procedures, as well as single-use injection cannulas for material application. Its portfolio also includes zirconia-based ceramic materials for dental crowns and bridges, ceramic inlays/onlays, and adhesive systems for bonding restorations. Additional products include ceramic powders, opacifiers, and try-in pastes for dental prosthetics.

These devices are classified as Class I or Class IIa under EU regulations and are registered in the eudamed database. The company is based in Liechtenstein.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue5,758

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Company details

EUDAMED SRN
LI-MF-000000522
FDA FEI number
3002808636
EU VAT number
50639
EUDAMED status
Active
EUDAMED registered name
Ivoclar Vivadent AG
Registered address
2, Bendererstrasse, 9494, Schaan, Liechtenstein
PRRC contact
Sandro Sbicego(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 4 May 2031

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G15 043306 0282 Active Supplemented

    Quality management system EU MDR

    Issued
    12 Jun 2026
    Expires
    4 May 2031
    Reason
    Add device or group

FDA recalls34

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 4
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 1
  • 2024 0
  • 2025 0
  • 2026 0

29 initiated before 2017

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. Distribution: US Nationwide distribution in the states IN and TN. Submission number: K820389

  • 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. Distribution: US and Canada Submission number: K884588
    • 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. Distribution: US and Canada Submission number: K884588
    • 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. Distribution: US and Canada Submission number: K884588
    • 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. Distribution: US and Canada Submission number: K884588

  • 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. Distribution: Worldwide Distribution - US Nationwide and the countries of Canada and Australia Submission number: K083739
    • 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. Distribution: Worldwide Distribution - US Nationwide and the countries of Canada and Australia Submission number: K083739
    • 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. Distribution: Worldwide Distribution - US Nationwide and the countries of Canada and Australia Submission number: K083739
    • 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. Distribution: Distributed in the states of CA, FL, GA, IA, IL, IN, KS, KY, MA, MI, NV, NY, OH, PA, TX, and WA.
    • 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. Distribution: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND,…
      Full distribution text US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
      Submission number: K152118
Show the 25 most recent of 34 recalls

  • 2016

    • 27 May 2016 Z-0018-2017 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. Distribution: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND,…
      Full distribution text US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
      Submission number: K152118
    • 27 May 2016 Z-0019-2017 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. Distribution: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND,…
      Full distribution text US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
      Submission number: K152118
    • 27 May 2016 Z-0020-2017 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. Distribution: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND,…
      Full distribution text US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
      Submission number: K152118
    • 27 May 2016 Z-0021-2017 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. Distribution: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND,…
      Full distribution text US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
      Submission number: K152118
    • 27 May 2016 Z-0022-2017 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. Distribution: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND,…
      Full distribution text US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
      Submission number: K152118
    • 27 May 2016 Z-0023-2017 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. Distribution: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND,…
      Full distribution text US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
      Submission number: K152118
    • 27 May 2016 Z-0024-2017 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. Distribution: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND,…
      Full distribution text US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
      Submission number: K152118
    • 27 May 2016 Z-0025-2017 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. Distribution: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND,…
      Full distribution text US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
      Submission number: K152118
    • 27 May 2016 Z-0026-2017 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. Distribution: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND,…
      Full distribution text US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
      Submission number: K152118
    • 27 May 2016 Z-0027-2017 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. Distribution: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND,…
      Full distribution text US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
      Submission number: K152118
    • 27 May 2016 Z-0028-2017 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. Distribution: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND,…
      Full distribution text US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
      Submission number: K152118
    • 27 May 2016 Z-0029-2017 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. Distribution: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND,…
      Full distribution text US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
      Submission number: K152118
    • 27 May 2016 Z-0030-2017 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. Distribution: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND,…
      Full distribution text US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
      Submission number: K152118
    • 27 May 2016 Z-0031-2017 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. Distribution: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND,…
      Full distribution text US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
      Submission number: K152118
    • 27 May 2016 Z-0032-2017 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. Distribution: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND,…
      Full distribution text US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
      Submission number: K152118

FDA establishments3

Registered with the FDA under this company group, matched by name.

  • 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

From the company website

Read 18 Oct 2026

Verändern Sie das Lächeln von Patienten mit den innovativen Lösungen von Ivoclar. Mit unseren effizienten Workflows und revolutionären Produkten erzielen Sie aussergewöhnliche Ergebnisse. Entdecken Sie Ivoclar.

From the manufacturer's own website, in their original language. Source

Frequently asked questions

How many devices does Ivoclar Vivadent AG have in the registry?

The registry currently lists 5758 devices for Ivoclar Vivadent AG. Devices recorded under merged duplicate company entries are counted once.

Are there FDA recall records for Ivoclar Vivadent AG?

FDA recall records list 34 recalls initiated by Ivoclar Vivadent AG, the most recent initiated on 21 Dec 2023. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Ivoclar Vivadent AG?

EUDAMED lists 1 certificate for Ivoclar Vivadent AG (quality management system) under MDR. The most recent was issued on 12 Jun 2026.

Which FDA establishments are linked to Ivoclar Vivadent AG?

3 FDA establishments are linked to Ivoclar Vivadent AG in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.