EAQ · Detector, Ultraviolet

Dental · 21 CFR 872.6350 · Class 2

Overview

Product CodeEAQ
Device NameDetector, Ultraviolet
Regulation21 CFR 872.6350
Device ClassClass 2
Review PanelDental
3rd-Party ReviewableYes

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.

Classification Rationale

Class II.

Recent Cleared Devices (2 of 2)

RecordDevice NameApplicantDecision DateDecision
K934728SUNSOR ULTRAVIOLET METERSunsor, Inc.Jul 28, 1994SESE
K770685LIGHT, EXAMINING, DENTAL, ULTRA VIOLETParker Laboratories, Inc.Apr 26, 1977SESE

Top Applicants

Innolitics

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