Charisma— 510(k) K160049
Substantially EquivalentHeraeus Kulzer, LLC (Mitsui Chemicals Group)
FDA 510(k) clearance K160049 for Charisma, Substantially Equivalent on 2016-11-15. Applicant: Heraeus Kulzer, LLC (Mitsui Chemicals Group).
Clearance details
- Applicant
- Heraeus Kulzer, LLC (Mitsui Chemicals Group)
- Product code
- Code EBF
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Bend, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.