# Sunstar Americas, Inc.

- Location (FDA's records): Lake Bluff, IL
- FDA decisions: 3 (2011–2018): 3 510(k) clearances
- Product codes: EJR (1), NPK (1), LFD (1)
- Predicates its devices cite: 10 (0 its own); citations of its devices by later devices: 1 (0 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
- John O. Butler Co.: 1 (https://510kreport.com/company/john-o-butler)
- Dentsply Intl.: 1 (https://510kreport.com/company/dentsply-intl)
- Premier Dental Products Co.: 1 (https://510kreport.com/company/premier-dental-products)
- Procordia Oratech AB: 1 (https://510kreport.com/company/procordia-oratech)
- W. L. Gore & Associates, Inc.: 1 (https://510kreport.com/company/w-l-gore-associates)
- Inion, Ltd.: 1 (https://510kreport.com/company/inion)
- Ed. Geistlich Soehne AG Fuer Chemische Industrie: 1 (https://510kreport.com/company/ed-geistlich-soehne-ag-fuer-chemische-industrie)
- Osteogenics Biomedical, Inc.: 1 (https://510kreport.com/company/osteogenics-biomedical)

## Firms that cite its devices most
- Procter & Gamble Co.: 1 (https://510kreport.com/company/procter-gamble)

## Its most-cited devices
- K181134: G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray (2018), cited by 1

## Recent decisions
- K181134: G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray (Jul 13, 2018)
- K132325: Guidor Bioresorbable Matrix Barrier (Oct 29, 2013)
- K102053: Butler Calci-Flor Prophylaxis Paste (Feb 3, 2011)

Source page: https://510kreport.com/company/sunstar-americas