# Cosmedent, Inc.

- Location (FDA's records): Chicago, IL
- FDA decisions: 28 (1986–2024): 28 510(k) clearances
- Product codes: EBF (12), EMA (4), EBD (3), KLE (2), EBG (2), EJR (1), EBC (1), ELW (1), LBH (1), MQC (1)
- 510(k) review time since 2016: median 74 days, against 108 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 6 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bisco, Inc.: 2 (https://510kreport.com/company/bisco)
- Ivoclar Vivadent, Inc.: 1 (https://510kreport.com/company/ivoclar-vivadent)

## Firms that cite its devices most
- Meta Biomed Co., Ltd.: 1 (https://510kreport.com/company/meta-biomed)
- Sterngold/Implamed: 1 (https://510kreport.com/company/sterngold-implamed)
- Bisco, Inc.: 1 (https://510kreport.com/company/bisco)
- Rhondium, Ltd.: 1 (https://510kreport.com/company/rhondium)

## Its most-cited devices
- K070583: Nano Composite (2007), cited by 2
- K854755: Renamel Esthetic Restorative System (1986), cited by 1
- K052501: Multiple Resin Tooth Bonding Agent (2005), cited by 1
- K921820: Renamel Esthetic Restorative System, Modification (1992), cited by 1
- K924132: E.Z. Temep, Temporary Filling Material (1993), cited by 1

## Recent decisions
- K240714: Insure® Universal; Insure® Universal Automix (Jul 24, 2024)
- K222435: Renamel® Microhybrid ;Renamel® Flowable Microhybrid (Oct 11, 2022)
- K211259: Renamel Bulkfill (Jun 24, 2021)
- K172707: Renamel Microfill (Dec 5, 2017)
- K163480: Renamel NANO +plus (Feb 24, 2017)
- K092730: Cosmedent Brushable Composite (Nov 20, 2009)
- K070583: Nano Composite (Apr 16, 2007)
- K060881: Temporary Crown & Bridge Resin (May 16, 2006)

Source page: https://510kreport.com/company/cosmedent