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510(k) Data Aggregation

K Number

Device Name

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

Manufacturer

Date Cleared

2024-07-30

(166 days)

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Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

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Applicant Name (Manufacturer) :

Shiva Products

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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