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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 4 of 14

Device	Model / Reference	Registries	Class	Status
Renamel® Microfill	6073C2	FDA UDI	Class II	Active
Renamel® Flowable Microfill	3011B4	FDA UDI	Class II	Active
Renamel® NANO™	6002S3	FDA UDI	Class II	Active
Extra Oral Polisher Superfine Point	414070	FDA UDI	Class I	Active
All Ceramic Polisher Intra Oral Medium Cup	414011	FDA UDI	Class I	Active
Renamel® NANO™ +plus	6005B1	FDA UDI	Class II	Active
Silanator	602116	FDA UDI	Class II	Active
Insure	602106	FDA UDI	Class II	Active
Renamel® Microfill	6151C4	FDA UDI	Class II	Active
Adjust	6242S2	FDA UDI	Class II	Active
Porcelain Repair Kit (Clear)	661015	FDA UDI	N/A	Active
Renamel® NANO™ +plus	6006B1	FDA UDI	Class II	Active
FlexiDisc Mini 5/8 Fine	402358	FDA UDI	Class I	Active
Renamel® NANO™ +plus	600635	FDA UDI	Class II	Active
Renamel® Microfill	615SB2	FDA UDI	Class II	Active
Renamel® NANO™ +plus	6005B2	FDA UDI	Class II	Active
White Plastic Nozzle Tips	203402	FDA UDI	Class I	Active
Renamel® NANO™	6001B0	FDA UDI	Class II	Active
Renamel NANO Compule Start Kit	600225	FDA UDI	N/A	Active
Insure	605104	FDA UDI	Class II	Active
Renamel® Microfill	607A35	FDA UDI	Class II	Active
Prevue	604102	FDA UDI	Class II	Active
All Ceramic Intra Oral Zirconia Cones	414002	FDA UDI	Class I	Active
Renamel® Flowable Microhybrid	7011A1	FDA UDI	Class II	Active
Renamel® Flowable Microhybrid	7011MI	FDA UDI	Class II	Active
Impressiv	70351P	FDA UDI	Class II	Active
Renamel® Microfill	6151C1	FDA UDI	Class II	Active
Renamel® NANO™ +plus	6006WI	FDA UDI	Class II	Active
Renamel® NANO™	6002A2	FDA UDI	Class II	Active
Insure Refill Kit	602025	FDA UDI	N/A	Active
Renamel® Posterior Body	6102B0	FDA UDI	Class II	Active
RSVP Light Body	505LD2	FDA UDI	Class II	Active
Renamel® Flowable Microhybrid	7011B1	FDA UDI	Class II	Active
25 Gauge Blue Tips	203105	FDA UDI	Class I	Active
Renamel® De-Mark™	7011DM	FDA UDI	Class II	Active
FlexiDisc Regular 3/4 Superfine	401434	FDA UDI	Class I	Active
Renamel® Microfill	6073DI	FDA UDI	Class II	Active
FlexiDisc Regular 1/2 Medium	401212	FDA UDI	Class I	Active
Renamel® Flowable Microhybrid	7011B3	FDA UDI	Class II	Active
Renamel® NANO™	6001D3	FDA UDI	Class II	Active
CosmeCore	62210B	FDA UDI	Class II	Active
Renamel® Microhybrid	6061C3	FDA UDI	Class II	Active
Renamel® Microfill	6071A4	FDA UDI	Class II	Active
Microhybrid Pediatric Compule Kit	606CPD	FDA UDI	N/A	Active
MirrorImage	6241A1	FDA UDI	Class II	Active
Microhybrid Compule Starter Kit	606215	FDA UDI	N/A	Active
PorcelEtch	663102	FDA UDI	Class II	Active
Renamel® Microfill	6073LO	FDA UDI	Class II	Active
Renamel® Microhybrid	6161A1	FDA UDI	Class II	Active
Renamel® Microhybrid	6131LI	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.