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510(k) K222127

Soft Palate Elevator by The Tmj Clinic PC — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2022
Date Received
July 18, 2022
Clearance Type
Abbreviated
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

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  • K253868 — QuietLab Pro (December 5, 2025)
  • K252161 — Hushd Avera (November 25, 2025)
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  • 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)
  • K251628 — Mandibular Advancement Device L07 (October 22, 2025)