FDA Product Code PLC: Sleep Appliances With Patient Monitoring
For The Treatment Of Night Time Snoring And Mild To Moderate Obstructive Sleep Apnea In Patients 18 Years Of Age Or Older While Also Measuring Patient Compliance To Oral Appliance Therapy.
Leading manufacturers include Somnomed, Inc., Airway Management, Inc. and Microdental, Inc..
10
Total
10
Cleared
231d
Avg days
2015
Since
Growing category -
2 submissions in the last 2 years
vs 1 in the prior period
Consistent review times:
229d avg (recent)
FDA 510(k) Cleared Sleep Appliances With Patient Monitoring Devices (Product Code PLC)
10 devices
Cleared
Aug 25, 2026
iNOS intraoral biosensor
Achaemenid, LLC
Dental
237d
Cleared
Apr 06, 2026
ProSomnus RPMO2 OSA Device (RPMO2 OSA)
Prosomnus Sleep Technologies
Dental
220d
Cleared
Oct 03, 2024
Rest Assure System
Somnomed, Inc.
Dental
338d
Cleared
Apr 10, 2020
Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac
Residential Home Sleep Services
Dental
420d
Cleared
Apr 19, 2019
OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor
Mark Abramson, D.D.S., Inc.
Dental
309d
Cleared
Nov 22, 2017
Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder
Prosomnous Sleep Technologies
Dental
63d
Cleared
Nov 16, 2017
Acrylic Herbst Appliance with Micro-Recorder
Gergen'S Orthodontic Lab
Dental
260d
Cleared
Nov 07, 2016
MicrO2 OSA Device with Micro-Recorder
Microdental, Inc.
Dental
147d
Cleared
Aug 10, 2016
TAP 3, TAP 1
Airway Management, Inc.
Dental
191d
Cleared
Jun 18, 2015
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, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder
Somnomed, Inc.
Dental
125d
About Product Code PLC - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code PLC since 2015, with 10 receiving FDA clearance (average review time: 231 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - PLC Product Code
FDA review times for PLC submissions have been consistent, averaging 229 days recently vs 232 days historically.
PLC devices are reviewed by the Dental panel. Browse all Dental devices →