SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX— 510(k) K140278

Substantially Equivalent

Somnomed, Inc.

FDA 510(k) clearance K140278 for SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX, Substantially Equivalent on 2014-06-20. Applicant: Somnomed, Inc..

Clearance details

Applicant: Somnomed, Inc.
Product code: Code LRK
Advisory panel: Dental
Date received: 2014-02-03
Decision date: 2014-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frisco, TX, US

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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.