Medical Device Manufacturer · US , Chicago , IL

Cosmedent, Inc. - FDA 510(k) Cleared Devices

28 submissions · 28 cleared · Since 1986

Recent clearances: Insure® Universal, Renamel® Microhybrid, Renamel Bulkfill

Total

Cleared

Denied

Cosmedent, Inc. has 28 FDA 510(k) cleared dental devices. Based in Chicago, US.

Latest FDA clearance: Jul 2024. Active since 1986.

Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Deltamed GmbH as regulatory consultant.

Cosmedent, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Cosmedent, Inc.

28 devices

1-12 of 28

COSMEDENT BRUSHABLE COMPOSITE

TEMPORARY CROWN & BRIDGE RESIN

K060881 · EBG

Dental · 46d

Cleared Dec 16, 2005

MULTIPLE (TOOTH DESENSITIZER)

K052263 · LBH

Dental · 119d

Cleared Oct 21, 2005

MULTIPLE RESIN TOOTH BONDING AGENT

K052501 · KLE

Dental · 38d

Cleared Dec 01, 2004

COSMEDENT PIT & FISSURE SEALANT

K042823 · EBC

Dental · 50d

Cleared Jun 17, 2004

MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)

K041229 · ELW

Dental · 38d

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Apr 27, 2026

Cosmedent, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Cosmedent, Inc.

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