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K Number
K253248

Validate with FDA (Live)

Device Name
Bright Cavity Liner
Manufacturer
Dmp Dental Industry S.A.
Date Cleared
2026-01-13

(106 days)

Product Code
EJK
Regulation Number
872.3250
Type
Traditional
Panel
Dental
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 872.3250 Calcium hydroxide cavity liner.

(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.