# Bisco, Inc.

- Location (FDA's records): Schaumburg, IL
- FDA decisions: 88 (1984–2025): 88 510(k) clearances
- Product codes: EBF (30), KLE (18), EMA (9), EBD (6), EJK (4), DYH (4), EBI (3), EBC (3), EBG (2), LBH (2), EBZ (2), ELR (1)
- 510(k) review time since 2016: median 128 days, against 134 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 49 (23 its own); citations of its devices by later devices: 81 (23 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Phoenix Dental, Inc.: 3 (https://510kreport.com/company/phoenix-dental)
- 3M Espe Dental Products: 2 (https://510kreport.com/company/3m-espe-dental-products)
- Dentsply Intl.: 2 (https://510kreport.com/company/dentsply-intl)
- Kuraray Co.: 2 (https://510kreport.com/company/kuraray)
- Reliance Orthodontic Products, Inc.: 2 (https://510kreport.com/company/reliance-orthodontic-products)
- Ribbond, Inc.: 1 (https://510kreport.com/company/ribbond)
- Ultradent Products, Inc.: 1 (https://510kreport.com/company/ultradent-products)
- Rizhao Huge Biomaterials Company, Ltd.: 1 (https://510kreport.com/company/rizhao-huge-biomaterials)

## Firms that cite its devices most
- Dmg USA, Inc.: 5 (https://510kreport.com/company/dmg-usa)
- Meta Biomed Co., Ltd.: 4 (https://510kreport.com/company/meta-biomed)
- Apex Dental Materials, Inc.: 4 (https://510kreport.com/company/apex-dental-materials)
- DiaDent Group International: 3 (https://510kreport.com/company/diadent-group-international)
- Kuraray America, Inc.: 3 (https://510kreport.com/company/kuraray-america)
- Ultradent Products, Inc.: 2 (https://510kreport.com/company/ultradent-products)
- Reliance Orthodontic Products, Inc.: 2 (https://510kreport.com/company/reliance-orthodontic-products)
- Innovative Bioceramix, Inc.: 2 (https://510kreport.com/company/innovative-bioceramix)

## Its most-cited devices
- K910860: All-Bond 2 (1991), cited by 7
- K955292: Aeliteflo (1995), cited by 4
- K063237: Theracal LC (2006), cited by 4
- K924151: Bisco D/C Resinomer (1992), cited by 4
- K945604: Ecliptomer (1995), cited by 4
- K915668: Bisco Cavity Cleanser (1992), cited by 4

## Recent decisions
- K250156: Choice 2 DC (Jul 11, 2025)
- K242816: Quantium (Dec 17, 2024)
- K192007: TheraBase, TheraBase Ca (Mar 17, 2020)
- K182917: FluoroCal (Nov 18, 2019)
- K180344: TheraCal DC (Apr 5, 2018)
- K171147: REVEAL Bulk (Aug 4, 2017)
- K162598: HAPI Seal (May 23, 2017)
- K163171: CeraClean (Apr 14, 2017)

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