LogoFDA 510(k) Search
K Number
K974369
Device Name
APOLLO 9500
Manufacturer
ION LASER TECHNOLOGY
Date Cleared
1998-01-06

(47 days)

Product Code
EBZ
Regulation Number
872.6070
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Source of illumination for curing dental restorative materials; and, Source of illumination for tooth whitening activities performed in dentistry.

Device Description

Not Found

AI/ML Overview

The provided text does not contain information about acceptance criteria or the study that proves the device meets the acceptance criteria. It is a 510(k) premarket notification approval letter for a device named "Apollo 9500" from the Food and Drug Administration (FDA).

The letter confirms that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use: "Source of illumination for curing dental restorative materials; and, Source of illumination for tooth whitening activities performed in dentistry."

Therefore, I cannot extract the requested information from this document.

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.