Morpheus— 510(k) K210636

Substantially Equivalent

S4S UK , Ltd.

FDA 510(k) clearance K210636 for Morpheus, Substantially Equivalent on 2022-02-15. Applicant: S4S UK , Ltd..

Clearance details

Applicant: S4S UK , Ltd.
Product code: Code LRK
Advisory panel: Dental
Date received: 2021-02-19
Decision date: 2022-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheffield, GB

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.