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K Number
K011666
Device Name
CHILLIT
Manufacturer
HEATSHIELD, INC.
Date Cleared
2001-08-06

(68 days)

Product Code
EAT,DYJ,EKZ,MLY
Regulation Number
872.1720
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
    1. COOLING HEAT SENSITIVE ORTHODONTIC WIRES
    1. TOPICAL ANESTHETIC
    1. PULP TEST THE VITALITY OF TEETH
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device named "Chillit." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter is a regulatory approval, stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses general controls, regulations, and contact information for further inquiries.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them based on the provided text. The document simply does not contain that type of information.

§ 872.1720 Pulp tester.

(a)
Identification. A pulp tester is an AC or battery powered device intended to evaluate the pulpal vitality of teeth by employing high frequency current transmitted by an electrode to stimulate the nerve tissue in the dental pulp.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.