ZAPnea Oral Appliance— 510(k) K173064

Name: FDA 510(k) clearance K173064
Creator: U.S. Food and Drug Administration
Published: 2019-03-08

Substantially Equivalent

B. Fareid, Dds, PC

FDA 510(k) clearance K173064 for ZAPnea Oral Appliance, Substantially Equivalent on 2019-03-08. Applicant: B. Fareid, Dds, PC. Device class: 2.

Clearance details

Applicant: B. Fareid, Dds, PC
Product code: Code LRK
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2017-09-29
Decision date: 2019-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingsburg, CA, US

Download summary PDF View on FDA.gov ↗

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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.