FDA 510(k) Applications for Medical Device Product Code "PLC"
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K160239 |
Airway Management, Inc. |
TAP 3, TAP 1 |
08/10/2016 |
K170606 |
Gergen's Orthodontic Lab |
Acrylic Herbst Appliance with Micro-Recorder |
11/16/2017 |
K181571 |
Mark Abramson, D.D.S., Inc |
OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor |
04/19/2019 |
K161624 |
MICRODENTAL, Inc. |
MicrO2 OSA Device with Micro-Recorder |
11/07/2016 |
K172859 |
Prosomnous Sleep Technologies |
Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder |
11/22/2017 |
K190353 |
Residential Home Sleep Services |
Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac |
04/10/2020 |
K150369 |
SOMNOMED INC. |
SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, Somn |
06/18/2015 |
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