510(k) clearance

PDR Airway Device

FDA 510(k) source

510(k) number

K262937

Applicant

Park Dental Research Corp.

Decision date

Oct 20, 2026

Date received

Aug 21, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

LRK

Device type

Device, Anti-Snoring

Device class

Class II

Regulation

21 CFR 872.5570

Advisory committee

Dental

Statement or summary

Summary

Third party

N

Location

Ardmore, OK, US