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510(k) K150369

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 by Somnomed, Inc. — Product Code PLC

K150369 is an FDA 510(k) premarket notification submitted by Somnomed, Inc. for the device "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". The FDA issued a decision of Substantially Equivalent on June 18, 2015. The device falls under product code PLC (Sleep Appliances With Patient Monitoring), a Class II device regulated under 21 CFR 872.5570. Somnomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2015
Date Received
February 13, 2015
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.

  • K261366 — Virtus (June 12, 2026)
  • K233497 — Rest Assure System (October 3, 2024)
  • K183443 — SomnoDent Avant (May 8, 2019)
  • K162306 — SomnoDent ALPHA (September 20, 2016)
  • 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)

Other clearances for product code PLC

  • K254304 — iNOS intraoral biosensor (August 25, 2026)
  • K252765 — ProSomnus RPMO2 OSA Device (RPMO2 OSA) (April 6, 2026)
  • K233497 — Rest Assure System (October 3, 2024)
  • 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)

FDA data resources