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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 3 of 14

Device	Model / Reference	Registries	Class	Status
Renamel® Microfill	6072B3	FDA UDI	Class II	Active
Renamel® Microfill	6151A2	FDA UDI	Class II	Active
Renamel® NANO™ +plus	6005D2	FDA UDI	Class II	Active
Renamel® Microfill	6073A5	FDA UDI	Class II	Active
Renamel® Microhybrid	6062B1	FDA UDI	Class II	Active
Renamel® Microfill	6073A4	FDA UDI	Class II	Active
Renamel® Microfill	6071C5	FDA UDI	Class II	Active
Renamel® Microhybrid	6061CO	FDA UDI	Class II	Active
Renamel® Flowable Microhybrid	7011A4	FDA UDI	Class II	Active
Renamel® Microhybrid	6061B3	FDA UDI	Class II	Active
Renamel® Microfill	607A25	FDA UDI	Class II	Active
Kwik	7031TA	FDA UDI	Class II	Active
Renamel® NANO™ +plus	6006MI	FDA UDI	Class II	Active
Bulkfill	6722A2	FDA UDI	Class II	Active
Insure	605106	FDA UDI	Class II	Active
Prevue	604105	FDA UDI	Class II	Active
Renamel® Microhybrid	6061C2	FDA UDI	Class II	Active
Renamel® Microhybrid	61310W	FDA UDI	Class II	Active
Renamel® Microfill	6072D3	FDA UDI	Class II	Active
FlexiDisc Regular 3/4 Extrafine Garnet	401634	FDA UDI	Class I	Active
Renamel® NANO™	6001A4	FDA UDI	Class II	Active
FlexiDisc 1/2 Superfine	401412	FDA UDI	Class I	Active
FlexiDisc 5/8 Medium	401258	FDA UDI	Class I	Active
Intra Oral Polisher Superfine Disc	414007	FDA UDI	Class I	Active
Renamel® NANO™	6001C4	FDA UDI	Class II	Active
Insure	602105	FDA UDI	Class II	Active
Renamel® Microfill	6151MI	FDA UDI	Class II	Active
FlexiWheel	403502	FDA UDI	Class I	Active
Renamel® Microfill	6151A5	FDA UDI	Class II	Active
Renamel® Microhybrid	6061A4	FDA UDI	Class II	Active
Renamel® Microfill	6073D3	FDA UDI	Class II	Active
Renamel® Microhybrid	6161D4	FDA UDI	Class II	Active
Renamel® Microfill	615SB1	FDA UDI	Class II	Active
Renamel® Microfill	6151A3	FDA UDI	Class II	Active
Renamel NANO +Plus	6005S20	FDA UDI	Class II	Active
Renamel® Flowable Microfill	3011MI	FDA UDI	Class II	Active
Renamel® Microfill	6151C5	FDA UDI	Class II	Active
Renamel® Microfill	607335	FDA UDI	Class II	Active
Insure	605108	FDA UDI	Class II	Active
Renamel® Microfill	615A15	FDA UDI	Class II	Active
All Ceramic Extra Oral Lithium Disilicate Cones	414061	FDA UDI	Class I	Active
MirrorImage	6244A2	FDA UDI	Class II	Active
RSVP Impression Material	505101	FDA UDI	Class II	Active
Renamel® Microfill	6073MI	FDA UDI	Class II	Active
Renamel® Microfill	6071LI	FDA UDI	Class II	Active
RSVP Light Body	505LA1	FDA UDI	Class II	Active
Renamel® Microfill	6071A1	FDA UDI	Class II	Active
PorcelEtch	663101	FDA UDI	Class II	Active
Renamel® Flowable Microhybrid	70110W	FDA UDI	Class II	Active
da Vinci	6120W1	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.