# Oratec Dental Products

- Location (FDA's records): Mchenry, IL
- FDA decisions: 3 (1976–1976): 3 510(k) clearances
- Product codes: ELW (2), EMA (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
- K760240: Impression Material, Triflex Silicone (Jul 26, 1976)
- K760238: Impression Material, Triflex Silicone (Jul 26, 1976)
- K760239: Cement, Ultra-Bond (Jul 26, 1976)

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