Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +— 510(k) K240446

Name: FDA 510(k) clearance K240446
Creator: U.S. Food and Drug Administration
Published: 2024-07-30

Substantially Equivalent

Shiva Products

FDA 510(k) clearance K240446 for Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +, Substantially Equivalent on 2024-07-30. Applicant: Shiva Products. Device class: 2.

Clearance details

Applicant: Shiva Products
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2024-02-15
Decision date: 2024-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palghar, IN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.