SLEEP SPLINT— 510(k) K060122

Name: FDA 510(k) clearance K060122
Creator: U.S. Food and Drug Administration
Published: 2006-05-19

Substantially Equivalent

Nakagawa Dental Clinic

FDA 510(k) clearance K060122 for SLEEP SPLINT, Substantially Equivalent on 2006-05-19. Applicant: Nakagawa Dental Clinic. Device class: 2.

Clearance details

Applicant: Nakagawa Dental Clinic
Product code: Code LRK
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2006-01-17
Decision date: 2006-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mineola, NY, US

Download summary PDF View on FDA.gov ↗

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K261366 — Virtus2026-06-12
K261251 — Snorbliss® Anti-Snoring Device2026-06-11
K261134 — Dormiva Anti-Snoring Mouth Guard2026-05-14

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.