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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

Newest first, rows 601-650 of 661

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  • High Viscosity Composite Temporary (Provisional) Material Ref K980799

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Dentin Bonding System Ref K894994

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Multiple Resin Tooth Bonding Agent Ref K052501

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cosmedent Core Paste Ref K040994

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Renamelize Polishing Paste Ref K862912

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • E.Z. Temep, Temporary Filling Material Ref K924132

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Renamel Esthetic Restorative System Ref K854755

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Primosplint System Ref K030832

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Multiple (Addition Silicone Impression Material) Ref K041229

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cosmedent Pit & Fissure Sealant Ref K042823

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Renamel Esthetic Restorative System, Modification Ref K921820

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Insure® Universal; Insure® Universal Automix Ref K240714

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Nano Composite Ref K070583

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Insure Porcelain Veneer Bonding System Ref K873356

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Renamel Sculpt Ref K993658

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Insure Match Mate Porcelain Veneer Try-In System Ref K894477

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ginda Guard Ref K011239

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Multiple (Tooth Desensitizer) Ref K052263

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Renamel Pack Ref K993659

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Instruments Ref 100IPCL

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Matrix Band Full Contact Large Ref 409202

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Matrix Band Full Contact Large Ref 409101

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Instruments Ref 1002630

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • RSVP Tray Ref 505UPP

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Luer Lock Tip Ref 203104

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Black Brush #1 Bent Ref 201211

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • FlexiDiamond Ref 502130

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • FlexiDiamond Ref 502145

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Instruments Ref 100SPSM

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • 408101

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Instruments Ref 100OCL

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • FlexiDiamond Ref 502245

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Instruments Ref 100200

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Instruments Ref 100C3L

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Instruments Ref 100SPML

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Matrix Band Full Contact Large Ref 409103

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Mini Mandrel Ref 402101

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • FlexiDiamond Ref 502230

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Instruments Ref 1008G3

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Instruments Ref 100100

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Instruments Ref 100C3C

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Instruments Ref 1008AL

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Instruments Ref 100OCS

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Mini FlexiBuff Ref 402612

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • RSVP Tray Ref 505LOW

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Instruments Ref 100M1

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Instruments Ref 100MULT

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Black Brush Ref 201112

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Compule Gun Ref 100GUN

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Instruments Ref 1008A

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

Rows 601-650 of 661

Showing 601-650 of 661

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