Cosmedent, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000045496 FEI 1450653
- Devices
- 661
- Registrations
- EUDAMEDFDA
- FDA recalls
- 21 ongoing
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Sas Exclusivas Dentales S.L.ES
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.
Catalogue
Search and filter all 661 devicesShowing 1-50 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
- Website
- www.cosmedent.com
- facebook.com/cosmedentinc
- [email protected]
- Phone
- +1 312 644 9586
- PRRC contact
- Gary Chuven
FDA recalls
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.
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.
Full distribution text
- 20 Jul 2023 Z-0211-2024 Class II Ongoing Reports were received the elastomer cup material is crumbling.
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.
Full distribution text
- 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.
From the company website
Cosmedent is your cosmetic dental supply company and more, offering continuing education courses for dentists. Click here to learn more.
Frequently asked questions
How many devices does Cosmedent, Inc. have in the registry?
The registry currently lists 661 devices for Cosmedent, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cosmedent, Inc.'s devices?
Among its 50 most recently registered devices, Cosmedent, Inc. has devices listed in EUDAMED (1 device), FDA 510(k) (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Cosmedent, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Cosmedent, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Cosmedent, Inc.?
FDA recall records list 2 recalls initiated by Cosmedent, Inc., the most recent initiated on 20 Jul 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 are the newest devices from Cosmedent, Inc. in the registry?
The most recently registered devices listed for Cosmedent, Inc. include TEMPORARY CROWN & BRIDGE RESIN, All Ceramic Intra Oral Lithium Disilicate Cones 414004, Renamel® Flowable Microfill 3011A1 and MirrorImage 6244A3.