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Light, Examining, Dental, Ultraviolet

FDA 510(k)

Class II (US FDA 510(k))

510(k) K770685

by Parker Laboratories, Inc.

Identifiers

510(k) Number
K770685 FDA 510(k)
FDA Product Code
EAQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.6350 FDA 510(k)
Regulation Number
872.6350 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Detector, Ultraviolet, classified under FDA Product Code EAQ, designed to emit ultraviolet light for dental examination purposes. It is intended to identify invisible materials such as dental plaque on or within teeth, aiding in diagnostic procedures within dental practice.

The device is supplied as a reusable medical instrument and has been granted FDA 510(k) clearance under Traditional review by the Dental (DE) Advisory Committee. It is intended for use in clinical dental settings and must comply with regulatory standards for ultraviolet light-emitting devices, including safety and performance requirements outlined in regulation number 872.6350. No specific sterility or MRI safety information is provided in the available data.

Frequently asked questions

What is the primary purpose of this ultraviolet dental examining light, and how does it assist in dental diagnostics?

This ultraviolet dental examining light is designed to emit ultraviolet light specifically for identifying invisible materials like dental plaque on or within teeth. By illuminating these materials under UV light, it helps dental professionals detect areas that may not be visible under normal lighting, thereby aiding in more accurate diagnostic procedures during dental examinations.

Is this device intended for single-use or reusable applications in a clinical setting?

The device is explicitly supplied as a reusable medical instrument, meaning it is meant to be used repeatedly in clinical dental settings after proper cleaning and maintenance. Unlike single-use devices, it requires adherence to standard infection control protocols to ensure safe reuse.

What regulatory pathway was followed for FDA clearance of this ultraviolet dental light?

This device received FDA clearance through the 510(k) Traditional review process, reviewed by the Dental (DE) Advisory Committee. The clearance was granted under the classification of Substantially Equivalent (SESE) to a predicate device, ensuring compliance with safety and performance standards outlined in regulation number 872.6350 for ultraviolet light-emitting dental instruments.

Are there any specific storage requirements or considerations mentioned for this ultraviolet dental light?

The provided data does not explicitly detail storage requirements, but as a reusable ultraviolet-emitting device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its functionality and prevent damage to the light source or components.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LIGHT, EXAMINING, DENTAL, ULTRA VIOLET - Innolitics, PDF K770685 - Light, Examining, Dental, Ultra Violet, Parker Laboratories | Ultrasound Gels & Medical Products, Products Archive - ParkerLabs, EAQ · Detector, Ultraviolet — FDA Product Code | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Parker Laboratories, Inc.

Sources (1)

  • FDA 510(k) K770685 24 fields · synced Sep 19, 2026