Home / 510(k) Clearances / K261134

510(k) K261134

Dormiva Anti-Snoring Mouth Guard by Koncept Innovators, Inc. — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2026
Date Received
April 7, 2026
Clearance Type
Special
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 Koncept Innovators, Inc.

  • K201484 — Somnos Anti-Snoring Mouth Guard (November 23, 2020)
  • K181099 — Bright Guard (January 18, 2019)

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)