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510(k) K121340

SOMNODENT G2 by Somnomed, Inc. — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2012
Date Received
May 3, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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.

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  • 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)
  • 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)

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  • 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)