Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +
K-Number: K240446 · 2024-07-30
Device Summary
Frequently Asked Questions
What is the Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +?
Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + is a medical device that received FDA 510(k) clearance on 2024-07-30. The listed applicant is Shiva Products. The 510(k) number is K240446.
When did Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + receive FDA 510(k) clearance?
Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + received FDA 510(k) clearance on 2024-07-30, under 510(k) number K240446.
Who is the listed applicant for Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +?
The FDA 510(k) record lists Shiva Products as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +?
The FDA product code for Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + is KIF.
Related Devices (Code: KIF)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.