510(k) K233497

Rest Assure System by Somnomed, Inc. — Product Code PLC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 3, 2024
Date Received: October 31, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Sleep Appliances With Patient Monitoring
Device Class: Class II
Regulation Number: 872.5570
Review Panel: DE
Submission Type

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.

Other clearances by Somnomed, Inc.

K183443 — SomnoDent Avant (May 8, 2019)
K162306 — SomnoDent ALPHA (September 20, 2016)
K150369 — SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac M (June 18, 2015)
K140278 — SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX (June 20, 2014)
K130558 — SOMNODENT HERBST; CLASSIC, FLEX (May 17, 2013)
K121340 — SOMNODENT G2 (May 30, 2012)
K102909 — SOMNOBRUX SPLINTS (December 13, 2011)
K102521 — PANTINO PRO POSITINER (March 28, 2011)
K073004 — SOMNOMED BFLEX (January 30, 2008)
K050592 — SOMNOMED MAS RXA (July 12, 2005)

Other clearances for product code PLC

K252765 — ProSomnus RPMO2 OSA Device (RPMO2 OSA) (April 6, 2026)
K190353 — Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac (April 10, 2020)
K181571 — OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor (April 19, 2019)
K172859 — Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device (November 22, 2017)
K170606 — Acrylic Herbst Appliance with Micro-Recorder (November 16, 2017)
K161624 — MicrO2 OSA Device with Micro-Recorder (November 7, 2016)
K160239 — TAP 3, TAP 1 (August 10, 2016)
K150369 — SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac M (June 18, 2015)