The following data is part of a premarket notification filed by Masterlink Llc with the FDA for Apex Dental Sensors.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D875S11685127105 | K163282 | 000 |
D875S11684127104 | K163282 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() APEX DENTAL SENSORS 86413934 4984112 Live/Registered |
Masterlink, LLC 2014-10-03 |