Not currently registered with FDA under this name
Heraeus Kulzer, LLC (Mitsui Chemicals Group)
South Bend, IN, United States. Named as applicant on 2 dental 510(k) clearances between 2015 and 2016. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22015–2016
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2007–2026
510(k) clearances
Clearances on which FDA names Heraeus Kulzer, LLC (Mitsui Chemicals Group) as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 15 Nov 2016 | K160049 | Charisma | EBF Resin Tooth Shade Material |
| 7 Jul 2015 | K150933 | iBond Universal & iBond Ceramic Primer | KLE Resin Tooth Bonding Agent |
Some of these clearances are listed with FDA today by another company: Kulzer, LLC (2).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.