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 ID | K203116 |
| 510k Number | K203116 |
| Device Name: | SensorX |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Durr Dental SE Hopfigheimer Str. 17 Bietigheim-bissingen, DE D-74321 |
| Contact | Oliver Lange |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Court Naples, FL 34114 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-16 |
| Decision Date | 2021-03-19 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E247G9520A1 | K203116 | 000 |
| E247G95201 | K203116 | 000 |
| E247G9510A1 | K203116 | 000 |
| E247G95101 | K203116 | 000 |
Trademark Results [SensorX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SENSORX 79159809 4783987 Live/Registered |
CathRx Ltd 2014-05-20 |
 SENSORX 79155424 not registered Dead/Abandoned |
Marel hf. 2014-03-26 |
 SENSORX 78207695 not registered Dead/Abandoned |
OMNII Products of Palm Beach 2003-01-28 |
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