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510(k) K140278

SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX by Somnomed, Inc. — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2014
Date Received
February 3, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Anti-Snoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

Other clearances by Somnomed, Inc.

  • K233497 — Rest Assure System (October 3, 2024)
  • 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)
  • 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 LRK

  • K252942 — ShaeferH (April 10, 2026)
  • K253845 — Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) (March 3, 2026)
  • K252531 — Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) (March 2, 2026)
  • K252976 — Park Dental Nylon MAD (December 18, 2025)
  • K253868 — QuietLab Pro (December 5, 2025)
  • K252161 — Hushd Avera (November 25, 2025)
  • K252525 — AIO Breathe (November 6, 2025)
  • K252698 — NightGuard Aire Max (November 3, 2025)
  • K253355 — Difiney Advanced Anti Snoring Device 4.0 (October 29, 2025)
  • K251784 — Hushd Pro Z-Link (October 24, 2025)