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Cosmedent, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000045496 FEI 1450653

Devices
661
Registrations
EUDAMEDFDA
FDA recalls
21 ongoing

What Cosmedent, Inc. makes

Cosmedent, Inc. manufactures dental composite resins, including flowable and microfill formulations such as Renamel® Flowable Microfill and Renamel® Microhybrid, as well as dental abrasive disks (both single-use and reusable), fatty acid dental cement, temporary dental crown/bridge resin, dental cement trial materials, reusable dental material injection cannulas, and professional dental abrasive materials. The company also produces related items such as instrument trays, matrix bands, and mirror imaging devices.

These devices are classified as Class I and Class II medical devices and are listed in the FDA’s Global Unique Device Identification Database (FDA UDI). Cosmedent, Inc. is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue661

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Company details

EUDAMED SRN
US-MF-000045496
FDA FEI number
1450653
DUNS number
113911689
EUDAMED status
Active
EUDAMED registered name
Cosmedent, Inc.
Registered address
401, NORTH MICHIGAN AVE., 60611, Chicago, United States
Phone
+1 312 644 9586
PRRC contact
Gary Chuven(public in EUDAMED)

FDA recalls2

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

FDA recall records list 2 recalls initiated by Cosmedent, Inc., the earliest on 2017-09-28 and the most recent on 2023-07-20. By recorded status: 1 ongoing and 1 terminated. The reasons filed fall into these groups: packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

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

  • 2023

    • 20 Jul 2023 Z-0211-2024 Class II Ongoing Reports were received the elastomer cup material is crumbling. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Colombia, Denmark Ecuador, Estonia, Greece,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Australia, Colombia, Denmark Ecuador, Estonia, Greece, Hungary, Iran, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Paraguay, Philippines, Spain, Sweden, UAE, and United Kingdom.

  • 2017

    • 28 Sep 2017 Z-0741-2018 Class II Terminated Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material. Distribution: Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and…
      Full distribution text Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain.
      Submission number: K052501

From the company website

Read 18 Sep 2026

Cosmedent is your cosmetic dental supply company and more, offering continuing education courses for dentists. Click here to learn more.

From the manufacturer's own website. Source