ULab Systems Dental Aligner Kit— 510(k) K192596

Substantially Equivalent

Ulab Systems, Inc.

FDA 510(k) clearance K192596 for ULab Systems Dental Aligner Kit, Substantially Equivalent on 2020-02-11. Applicant: Ulab Systems, Inc..

Clearance details

Applicant: Ulab Systems, Inc.
Product code: Code NXC
Advisory panel: Dental
Date received: 2019-09-20
Decision date: 2020-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NXC

product code NXC

Injury: 15,206
Malfunction: 2,576
Other: 9
Total: 17,791

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.