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K Number
K111828
Device Name
CLEARSPLINT ES
Manufacturer
ASTRON DENTAL CORPORATION
Date Cleared
2011-10-26

(120 days)

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

Clearsplint ES is a heat cured, moldable, acrylic compound for use in the fabrication of dental appliances and dental prostheses devices including TMJ splint appliances, night guards, bruxism appliances and other devices as prescribed.

Device Description

Clearsplint ES is a heat cured, moldable, acrylic compound.

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental material called "Clearsplint ES." This document does not contain information about acceptance criteria, device performance described by specific metrics, or any studies using AI or human readers.

Therefore, I cannot provide the requested information based on the input. The document is strictly a regulatory approval for a medical device (a dental material), stating that it is substantially equivalent to a predicate device. It does not describe any performance studies or AI-related assessments.

N/A