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Cosmedent, Inc.

United States·US-MF-000045496

Last updated September 18, 2026

About

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

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.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Cosmedent, Inc. manufacture?

Where is Cosmedent, Inc. based?

Cosmedent, Inc. is based in the United States, as stated in the provided device data under the COUNTRY field.

In which regulatory registry are Cosmedent, Inc.'s devices listed?

Cosmedent, Inc.'s devices are listed in the FDA’s Global Unique Device Identification Database (FDA UDI), as indicated in the LISTED IN field of the device data.

How are Cosmedent, Inc.'s devices classified under medical device regulations?

Cosmedent, Inc.'s devices are classified as Class I and Class II medical devices, as specified in the DEVICE CLASSES field of the provided data.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 401, NORTH MICHIGAN AVE., Chicago, United States
Website: www.cosmedent.com
LinkedIn: linkedin.com/company/cosmedent-inc-
Facebook: facebook.com/cosmedentinc
Email: [email protected]
Phone: +1 312 644 9586
PRRC Contact: Gary Chuven
EUDAMED SRN: US-MF-000045496
FDA FEI Number: 1450653
DUNS Number: —

Catalogue (658)

Page 2 of 14

Device	Model / Reference	Registries	Class	Status
Renamel® Microfill	601SB3	FDA UDI	Class II	Active
Renamel® Microfill	6072DI	FDA UDI	Class II	Active
Adjust	6242A2	FDA UDI	Class II	Active
Prevue	604106	FDA UDI	Class II	Active
Renamel® Flowable Microfill	3011D4	FDA UDI	Class II	Active
Renamel® Microfill	6073A1	FDA UDI	Class II	Active
Renamel® Microhybrid	6061MI	FDA UDI	Class II	Active
Renamel® Microfill	6073S1	FDA UDI	Class II	Active
Renamel® Microfill	607325	FDA UDI	Class II	Active
Renamel® Microhybrid	6061C4	FDA UDI	Class II	Active
RSVP Light Body	505LB0	FDA UDI	Class II	Active
Renamel® Microhybrid	6061C1	FDA UDI	Class II	Active
Renamel® Microhybrid	6161CO	FDA UDI	Class II	Active
Renamel® NANO™	6002C2	FDA UDI	Class II	Active
Bulkfill	672235	FDA UDI	Class II	Active
Renamel® Microfill	601SB1	FDA UDI	Class II	Active
FlexiDisc Regular All Purpose Kit	401000	FDA UDI	Class I	Active
Nano/Microhybrid Diamond Polisher Medium Point	4121MP	FDA UDI	Class I	Active
Renamel® Microfill	6073B1	FDA UDI	Class II	Active
Renamel® Microhybrid	6062D3	FDA UDI	Class II	Active
Renamel® Microfill	6151D4	FDA UDI	Class II	Active
Renamel® Microhybrid	6061D4	FDA UDI	Class II	Active
Renamel® Posterior Body	6101B0	FDA UDI	Class II	Active
FlexiDisc Mini 1/2 Fine	402312	FDA UDI	Class I	Active
Renamel® Microhybrid	6062MI	FDA UDI	Class II	Active
FlexiDisc Mini Assort Pack 5/8	4025CS	FDA UDI	Class I	Active
da Vinci	7120W3	FDA UDI	Class II	Active
Renamel® NANO™ +plus	6005A2	FDA UDI	Class II	Active
FlexiDisc Regular 5/8 Coarse Sand	401558	FDA UDI	Class I	Active
Renamel® NANO™ +plus	6005C2	FDA UDI	Class II	Active
Renamel® NANO™	6001C2	FDA UDI	Class II	Active
Renamel® Microfill	6073A6	FDA UDI	Class II	Active
Renamel® Microhybrid	6161MI	FDA UDI	Class II	Active
Renamel Microhybrid Pedo Kit	606PED	FDA UDI	N/A	Active
Renamel® Microfill	60110W	FDA UDI	Class II	Active
Renamel® NANO™ +plus	6006S2	FDA UDI	Class II	Active
CosmeCore	62270W	FDA UDI	Class II	Active
BulkFill	600BFF	FDA UDI	Class II	Active
Renamel® Flowable Microhybrid	7011A2	FDA UDI	Class II	Active
Renamel® Microhybrid	6161C4	FDA UDI	Class II	Active
Renamel® NANO™	600SB3	FDA UDI	Class II	Active
Renamel® NANO™	6002D3	FDA UDI	Class II	Active
Etching Gel Kit	663005	FDA UDI	N/A	Active
Renamel® Microfill	6151DI	FDA UDI	Class II	Active
MirrorImage	6241A2	FDA UDI	Class II	Active
Creative Color®	6031A4	FDA UDI	Class II	Active
da Vinci	6120W4	FDA UDI	Class II	Active
Prevue	604104	FDA UDI	Class II	Active
All Ceramic Extra Oral Zirconia Cones	414052	FDA UDI	Class I	Active
Creative Color®	6031B3	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

SAS Exclusivas Dentales S.L. ES

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Cosmedent, Inc. has two recall records. The earliest was initiated on September 28, 2017, and the most recent on July 20, 2023. The statuses of these recalls are open, classified, and terminated. The reasons given include product packaged in a syringe that is not a luer lock syringe and the tip may come off when expressing the material, and reports that the elastomer cup material is crumbling.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jul 20, 2023	Z-0211-2024	—	open, classified	Reports were received the elastomer cup material is crumbling.
Sep 28, 2017	Z-0741-2018	—	terminated	Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.