PDR Airway Device— 510(k) K262937

Name: FDA 510(k) clearance K262937
Creator: U.S. Food and Drug Administration
Published: 2026-10-20

Substantially Equivalent

Park Dental Research Corp.

FDA 510(k) clearance K262937 for PDR Airway Device, Substantially Equivalent on 2026-10-20. Applicant: Park Dental Research Corp.. Device class: 2.

Clearance details

Applicant: Park Dental Research Corp.
Product code: Product code LRK
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2026-08-21
Decision date: 2026-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ardmore, OK, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LRK

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K260136 — Forza2026-10-06
K262104 — Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)2026-08-27
K261912 — SnØreNegatØr2026-07-31
K261366 — Virtus2026-06-12
K261251 — Snorbliss® Anti-Snoring Device2026-06-11

More clearances from Park Dental Research Corp.

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K252976 — Park Dental Nylon MAD2025-12-18
K121707 — LEW MDI O-BALL COLLARED IMPLANT,2012-09-24
K082800 — STAR/VENT INTERNAL HEX SCREW IMPLANT2010-08-26
K854749 — STARTANIUS DENTAL IMPLANT SYSTEM1986-03-06

Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.