# Heraeus Kulzer, Inc., Dental Products Division

- Location (FDA's records): South Bend, IN
- FDA decisions: 1 (2008–2008): 1 510(k) clearance
- Product codes: ELW (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
- K082591: Flexitime Bite (Dec 5, 2008)

Source page: https://510kreport.com/company/heraeus-kulzer-dental-products-division