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 ID | K163282 |
| 510k Number | K163282 |
| Device Name: | Apex Dental Sensors |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Masterlink LLC 24654 N. Lake Pleasant Parkway Suite 103-501 Peoria, AZ 85383 |
| Contact | Tom Birney |
| Correspondent | Parul Chansoria Elexes 6494 Tralee Village Dr. Dublin, CA 94568 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-21 |
| Decision Date | 2017-02-28 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D875S11685127105 | K163282 | 000 |
| D875S11684127104 | K163282 | 000 |
Trademark Results [Apex Dental Sensors]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 APEX DENTAL SENSORS 86413934 4984112 Live/Registered |
Masterlink, LLC 2014-10-03 |
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