SensorX

System, X-ray, Extraoral Source, Digital

Durr Dental SE

The following data is part of a premarket notification filed by Durr Dental Se with the FDA for Sensorx.

Pre-market Notification Details

Device IDK203116
510k NumberK203116
Device Name:SensorX
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant Durr Dental SE Hopfigheimer Str. 17 Bietigheim-bissingen,  DE D-74321
ContactOliver Lange
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Court Naples,  FL  34114
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-16
Decision Date2021-03-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E247G9520A1 K203116 000
E247G95201 K203116 000
E247G9510A1 K203116 000
E247G95101 K203116 000

Trademark Results [SensorX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SENSORX
SENSORX
79159809 4783987 Live/Registered
CathRx Ltd
2014-05-20
SENSORX
SENSORX
79155424 not registered Dead/Abandoned
Marel hf.
2014-03-26
SENSORX
SENSORX
78207695 not registered Dead/Abandoned
OMNII Products of Palm Beach
2003-01-28

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