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

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.

Clearance details

Applicant: Meris Investment Group
Product code: Code LRK
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 ↗

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.