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Apex Dental Sensors

FDA 510(k)

Class II (US FDA 510(k))

510(k) K163282

by Masterlink, LLC

Identifiers

510(k) Number
K163282 FDA 510(k)
FDA Product Code
MUH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.1800 FDA 510(k)
Regulation Number
872.1800 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Apex Dental Sensors are digital intraoral radiography systems used for capturing dental X-ray images. These sensors are designed to provide high-quality dental imaging for diagnostic purposes in dental practices.

The Apex Dental Sensors are supplied as part of a digital dental imaging system and are intended for single-use or multiple-use depending on the specific model. They are regulated as Class II medical devices under product code MUH and have received FDA 510(k) clearance with the K number K163282. The sensors are available in various sizes and models as specified by the manufacturer.

Frequently asked questions

What are Apex Dental Sensors used for?

Apex Dental Sensors are digital intraoral radiography systems designed for capturing dental X-ray images to provide high-quality dental imaging for diagnostic purposes in dental practices.

Are Apex Dental Sensors single-use or reusable?

The Apex Dental Sensors can be supplied for either single-use or multiple-use depending on the specific model selected by the dental practice.

What sizes and models are available for Apex Dental Sensors?

The sensors are available in various sizes and models as specified by the manufacturer, Masterlink, LLC, to accommodate different dental imaging needs.

What is the regulatory classification of Apex Dental Sensors?

Apex Dental Sensors are regulated as Class II medical devices under product code MUH and have received FDA 510(k) clearance with K number K163282.

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: Masterlink Support | Apex Dental Sensors Support, Dental Sensors at an affordable price | Apex Dental Sensors, Home - Digital Dental Equipment - DentalStore123.com, Masterlink, LLC. Launches New Apex Dental Sensor Intraoral ... - PRWeb

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Masterlink, LLC

Sources (1)

  • FDA 510(k) K163282 24 fields · synced Sep 22, 2026