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510(k) K252976

Park Dental Nylon MAD by Park Dental Research Corp. — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2025
Date Received
September 17, 2025
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 Park Dental Research Corp.

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  • K082800 — STAR/VENT INTERNAL HEX SCREW IMPLANT (August 26, 2010)
  • K854749 — STARTANIUS DENTAL IMPLANT SYSTEM (March 6, 1986)

Other clearances for product code LRK

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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)
  • K250028 — Anti Snore Mouthpiece (October 3, 2025)