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FDA 510(k)

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

Número K: K240446 · 2024-07-30

RequerenteShiva Products
Data da decisão2024-07-30
Código do produtoKIF
Comité consultivoDE
DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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.

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