Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)— 510(k) K203606

Name: FDA 510(k) clearance K203606
Creator: U.S. Food and Drug Administration
Published: 2021-03-10

Substantially Equivalent

Meris Investment Group

FDA 510(k) clearance K203606 for Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA), Substantially Equivalent on 2021-03-10. Applicant: Meris Investment Group. Device class: 2.

Clearance details

Applicant: Meris Investment Group
Product code: Code LRK
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2020-12-10
Decision date: 2021-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakeland, MN, US

Download summary PDF View on FDA.gov ↗

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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.