Apex Dental Sensors

System, X-ray, Extraoral Source, Digital

Masterlink LLC

The following data is part of a premarket notification filed by Masterlink Llc with the FDA for Apex Dental Sensors.

Pre-market Notification Details

Device IDK163282
510k NumberK163282
Device Name:Apex Dental Sensors
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant Masterlink LLC 24654 N. Lake Pleasant Parkway Suite 103-501 Peoria,  AZ  85383
ContactTom Birney
CorrespondentParul Chansoria
Elexes 6494 Tralee Village Dr. Dublin,  CA  94568
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-21
Decision Date2017-02-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D875S11685127105 K163282 000
D875S11684127104 K163282 000

Trademark Results [Apex Dental Sensors]

Mark Image

Registration | Serial
Company
Trademark
Application Date
APEX DENTAL SENSORS
APEX DENTAL SENSORS
86413934 4984112 Live/Registered
Masterlink, LLC
2014-10-03

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