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K Number
K121282
Device Name
MICROLUX/DL MICROLUX/BLU BIO/SCREEN
Manufacturer
ADDENT, INC.
Date Cleared
2012-07-24

(85 days)

Product Code
NXV
Regulation Number
872.6350
Type
Traditional
Panel
DE
Reference & Predicate Devices
K041614,K072309,K082668
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ORABLU Oral Lesion Marking System is a three component swab system intended to be used by a dentist as an adjunct to traditional oral examination by incandescent light, combined with further examination with one of three oral examination lights manufactured by AdDent, Inc. The Microlux DL (K041614), Microlux BLU (K072309), and Bio/Screen (K082668). The ORABLU Oral Lesion Marking System is used as an aid to enhance the visualization of oral mucosal irregularities by physically marking areas of oral mucosa that may warrant further investigation.

Device Description

The ORABLU Oral Lesion Marking System is a three component swab system.

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for the ORABLU Oral Lesion Marking System. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms substantial equivalence to a predicate device and states that the device can be marketed.

Therefore, I cannot provide the requested information based on the provided text.

§ 872.6350 Ultraviolet detector.

(a)
Identification. An ultraviolet detector is a device intended to provide a source of ultraviolet light which is used to identify otherwise invisible material, such as dental plaque, present in or on teeth.(b)
Classification. Class II.