# Apex Dental Materials, Inc.

- Location (FDA's records): Lake Zurich, IL
- FDA decisions: 15 (2001–2019): 15 510(k) clearances
- Product codes: KLE (8), EBF (5), EBC (1), DYH (1)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bisco, Inc.: 4 (https://510kreport.com/company/bisco)
- Pulpdent Corp.: 1 (https://510kreport.com/company/pulpdent)
- Health-Dent Intl., Inc.: 1 (https://510kreport.com/company/health-dent-intl)
- Advantage Dental Products, Inc.: 1 (https://510kreport.com/company/advantage-dental-products)

## Firms that cite its devices most
- Enamelite, LLC: 1 (https://510kreport.com/company/enamelite)
- Elevate Oral Care: 1 (https://510kreport.com/company/elevate-oral-care)

## Its most-cited devices
- K120620: Clean and Boost (2012), cited by 1
- K020570: Simplicity (2002), cited by 1
- K061981: Surpass (2006), cited by 1

## Recent decisions
- K190998: BA Pit & Fissure Sealant (Nov 8, 2019)
- K161077: RnD TE and RnD SE (Mar 17, 2017)
- K131043: Apex Universal Adhesive (Sep 10, 2013)
- K131049: ZRP (Aug 27, 2013)
- K120620: Clean and Boost (May 31, 2012)
- K110859: Metal Opaquer (Jun 23, 2011)
- K092539: Seamfree (Oct 1, 2009)
- K091647: Injectafil (Sep 21, 2009)

Source page: https://510kreport.com/company/apex-dental-materials