Cleared Traditional

Park Dental Nylon MAD

K252976 · Park Dental Research Corp. · Dental

Dec 2025

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K252976 is an FDA 510(k) clearance for the Park Dental Nylon MAD, a Device, Anti-snoring (Class II — Special Controls, product code LRK), submitted by Park Dental Research Corp. (Ardmore, US). The FDA issued a Cleared decision on December 18, 2025, 92 days after receiving the submission on September 17, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number	K252976 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 17, 2025
Decision Date	December 18, 2025
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF