FDA.reportPublic FDA data

510(k) K233497

Device
Rest Assure System
Applicant
Somnomed, Inc.
510(k) number
K233497
Product code
PLC
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-03
Date received
2023-10-31
Regulation
872.5570
Classification name
Sleep Appliances With Patient Monitoring
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ty Cowart
Address
6513 Windcrest Dr., Suite 100 Plano TX US 75024 75024

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PLC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies2026-04-06
K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services2020-04-10
K181571OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient MonitorMark Abramson, D.D.S., Inc.2019-04-19
K172859Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorderProsomnous Sleep Technologies2017-11-22
K170606Acrylic Herbst Appliance with Micro-RecorderGergen'S Orthodontic Lab2017-11-16
K161624MicrO2 OSA Device with Micro-RecorderMicrodental, Inc.2016-11-07
K160239TAP 3, TAP 1Airway Management, Inc.2016-08-10
K150369SomnoDent 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-recorderSomnomed, Inc.2015-06-18