LogoFDA 510(k) Search
K Number
K964191
Device Name
CALCIUM HYDROXIDE MEDICAMENT
Manufacturer
SYBRON DENTAL SPECIALTIES, INC.
Date Cleared
1997-01-22

(93 days)

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

§ 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.