K240446
- 510(k) number
- K240446
- Device name
- Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +
- Applicant
- Shiva Products IN
- Product code
- KIF — Resin, Root Canal Filling
- Decision date
- 2024-07-30
- Date received
- 2024-02-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K240446.pdf
Official FDA record: K240446
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.