LogoFDA 510(k) Search
K Number
K060365
Device Name
APEXCAL
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2006-04-17

(63 days)

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

ApexCAL is a Calcium Hydroxide paste that has a creamy consistency and is suitable for several indications including:

  • Temporary disinfectant dressings in the obturation of root canals; .
  • Indirect pulp capping or management of deep caries lesions; or
  • Direct pulp capping. .
Device Description

ApexCAL is a Calcium Hydroxide paste that has a creamy consistency

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental device called ApexCal. This document primarily focuses on regulatory approval and does not contain the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot extract the requested information from this text.

§ 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.