# Orasystems

- Location (FDA's records): Morris Plains, NJ
- FDA decisions: 3 (2000–2000): 3 510(k) clearances
- Product codes: EFB (2), ELC (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K000846: TKD Scalers (Dec 4, 2000)
- K000848: TDK Handpieces (Oct 5, 2000)
- K000847: Oralube (Sep 27, 2000)

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