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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

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 1 of 14

Device	Model / Reference	Registries	Class	Status
All Ceramic Intra Oral Lithium Disilicate Cones	414004	FDA UDI	Class I	Active
Renamel® Flowable Microfill	3011A1	FDA UDI	Class II	Active
MirrorImage	6244A3	FDA UDI	Class II	Active
Brush White #3	201103	FDA UDI	Class I	Active
Matrix Bands Pedo	409102	FDA UDI	Class I	Active
Insure	602108	FDA UDI	Class II	Active
Instrument Tray	901106	FDA UDI	Class I	Active
Renamel® Posterior Body	6101A2	FDA UDI	Class II	Active
Renamel® Microfill	60720W	FDA UDI	Class II	Active
Renamel® Microhybrid	6161C1	FDA UDI	Class II	Active
Renamel® Microhybrid	6161B4	FDA UDI	Class II	Active
Renamel® Microhybrid	6062D4	FDA UDI	Class II	Active
Renamel® Microfill	607315	FDA UDI	Class II	Active
Insure	605101	FDA UDI	Class II	Active
Renamel® Microfill	6073C5	FDA UDI	Class II	Active
Renamel® Microfill	6072D4	FDA UDI	Class II	Active
Renamel® Microfill	6072C4	FDA UDI	Class II	Active
Renamel® Microfill	6151B3	FDA UDI	Class II	Active
Renamel® NANO™ +plus	6006A1	FDA UDI	Class II	Active
Creative Color®	60310V	FDA UDI	Class II	Active
Renamel® Microhybrid	6062B0	FDA UDI	Class II	Active
Intra Oral Polisher Medium Disc	414012	FDA UDI	Class I	Active
Renamel® Microfill	6071D3	FDA UDI	Class II	Active
Renamel® Microfill	6073A3	FDA UDI	Class II	Active
Renamel® Microfill	6071C3	FDA UDI	Class II	Active
Renamel® Microfill	6072A2	FDA UDI	Class II	Active
Renamel® Microfill	6072S3	FDA UDI	Class II	Active
Creative Color®	6031LB	FDA UDI	Class II	Active
Renamel® Microfill	6073D4	FDA UDI	Class II	Active
Renamel® Microfill	6071MI	FDA UDI	Class II	Active
Renamel® Posterior Body	6102A2	FDA UDI	Class II	Active
FlexiCup Superfine	403102	FDA UDI	Class I	Active
Renamel® Microfill	607A15	FDA UDI	Class II	Active
Insure	602104	FDA UDI	Class II	Active
Renamel® Gingafill	609104	FDA UDI	Class II	Active
CosmeSeal	61710W	FDA UDI	Class II	Active
Insure	602103	FDA UDI	Class II	Active
Renamel® Microfill	6073C4	FDA UDI	Class II	Active
IPC Off-Angle Long	100ROD	FDA UDI	Class I	Active
Renamel® Microfill	6151LO	FDA UDI	Class II	Active
FlexiStrips Narrow Coarse/Medium	501CMN	FDA UDI	Class I	Active
Adjust	6242A1	FDA UDI	Class II	Active
Complete Primer/Unfilled Resin	654102	FDA UDI	Class II	Active
Renamel® Microfill	6071C1	FDA UDI	Class II	Active
Da Vinci Kit	612005	FDA UDI	N/A	Active
Renamel® NANO™ +plus	6006D2	FDA UDI	Class II	Active
Renamel® Microfill	6072LI	FDA UDI	Class II	Active
Renamel® Flowable Microhybrid	7011CO	FDA UDI	Class II	Active
Brush Cleaner	603115	FDA UDI	Class I	Active
Prevue Try-In Kit	604005	FDA UDI	N/A	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.

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.