# Roydent Dental Products, Inc.

- Location (FDA's records): Rochester Hills, MI
- FDA decisions: 3 (1996–1999): 3 510(k) clearances
- Product codes: EBI (1), ELW (1), EBD (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 4 (0 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
- Dentsply Intl.: 1 (https://510kreport.com/company/dentsply-intl)
- Tokuyama America, Inc.: 1 (https://510kreport.com/company/tokuyama-america)
- Sybron Dental Specialties, Inc.: 1 (https://510kreport.com/company/sybron-dental-specialties)
- Austenal, Inc.: 1 (https://510kreport.com/company/austenal)

## Firms that cite its devices most
- Kettenbach GmbH & Co. KG: 2 (https://510kreport.com/company/kettenbach)
- Osstem Germany GmbH: 1 (https://510kreport.com/company/osstem-germany)
- Espe Dental AG: 1 (https://510kreport.com/company/espe-dental)

## Its most-cited devices
- K954281: Panasil Impression Material (1996), cited by 4

## Recent decisions
- K984037: Core-Ide (Feb 4, 1999)
- K983357: Mucopren Soft Relining System (Nov 13, 1998)
- K954281: Panasil Impression Material (Jun 24, 1996)

Source page: https://510kreport.com/company/roydent-dental-products