3D Predict— 510(k) K200214

Substantially Equivalent

3D Smile USA, Inc.

FDA 510(k) clearance K200214 for 3D Predict, Substantially Equivalent on 2020-02-24. Applicant: 3D Smile USA, Inc..

Clearance details

Applicant: 3D Smile USA, Inc.
Product code: Code NXC
Advisory panel: Dental
Date received: 2020-01-28
Decision date: 2020-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, 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.