DailyMate Orthodontic Aligner System— 510(k) K212803

Substantially Equivalent

3D Global Biotech, Inc.

FDA 510(k) clearance K212803 for DailyMate Orthodontic Aligner System, Substantially Equivalent on 2022-05-23. Applicant: 3D Global Biotech, Inc..

Clearance details

Applicant: 3D Global Biotech, Inc.
Product code: Code NXC
Advisory panel: Dental
Date received: 2021-09-02
Decision date: 2022-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City 221, TW

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.