510(k) K252976

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

K252976 is an FDA 510(k) premarket notification submitted by Park Dental Research Corp. for the device "Park Dental Nylon MAD". The FDA issued a decision of Substantially Equivalent on December 18, 2025. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Park Dental Research Corp. has at least 3 other 510(k) clearances on record.

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