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510(k) Data Aggregation

K Number

Device Name

Manufacturer

IVOCLAR VIVADENT, INC.

Date Cleared

2006-04-17

(63 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

APEXCAL

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.

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