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FDA 510(k)

Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +

K-Number: K240446 · 2024-07-30

ApplicantShiva Products
Decision Date2024-07-30
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + is a medical device manufactured by Shiva Products. It received FDA 510(k) clearance on 2024-07-30 under approval number K240446. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

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. It is manufactured by Shiva Products. The 510(k) number is K240446.

When was Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + approved by the FDA?

Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + received FDA 510(k) clearance on 2024-07-30, under approval number K240446.

What company makes 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 manufactured by Shiva Products.

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)

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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.

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