Cleared Traditional

K163282 - Apex Dental Sensors

K163282 is an FDA 510(k) clearance for Apex Dental Sensors, manufactured by Masterlink, LLC. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K163282 · Masterlink, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
99d
Days
Class 2
Risk

K163282 is an FDA 510(k) clearance for the Apex Dental Sensors. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Masterlink, LLC (Peoria, US). The FDA issued a Cleared decision on February 28, 2017 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Masterlink, LLC devices

FDA 510(k) Submission Details - K163282

510(k) Number K163282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2016
Decision Date February 28, 2017
Days to Decision 99 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 107d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUH Device Classification - Class 2, Special Controls

Product Code MUH System, X-ray, Extraoral Source, Digital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MUH System, X-ray, Extraoral Source, Digital

All 95
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K163282.
Aurora
K181636 · Sodium Systems, LLC · Jul 2018
Televere Digital Dental Imaging System
K181358 · Televere Systems, Inc. · Jun 2018
System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight
K170731 · VATECH Co., Ltd. · Apr 2017
RIOScan (RPS500)
K160788 · Ray Co., Ltd. · Apr 2016
Myray- HYPERION X5
K152162 · Cefla S.C. · Dec 2015
Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S
K153060 · Rayence Co., Ltd. · Nov 2015